{"id":3422,"date":"2022-02-24T13:58:28","date_gmt":"2022-02-24T13:58:28","guid":{"rendered":"https:\/\/pharma-expertise.com\/?page_id=3422"},"modified":"2022-10-27T09:37:48","modified_gmt":"2022-10-27T09:37:48","slug":"medical-devices","status":"publish","type":"page","link":"https:\/\/pharma-expertise.com\/en\/medical-devices\/","title":{"rendered":"Medical Devices"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_fullwidth_image src=&#8221;https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/10\/top_pharma-medizinprodukte-min.jpg&#8221; alt=&#8221;Pharma &#038; Medizinprodukte&#8221; title_text=&#8221;Medizinprodukte&#8221; _builder_version=&#8221;4.17.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;About&#8221; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; custom_margin=&#8221;||0px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.17.4&#8243; text_font=&#8221;Manrope||||||||&#8221; text_line_height=&#8221;2em&#8221; header_font=&#8221;Manrope|600|||||||&#8221; header_text_color=&#8221;#20292f&#8221; header_font_size=&#8221;26px&#8221; header_line_height=&#8221;1.3em&#8221; header_2_font=&#8221;Manrope|600||on|||||&#8221; header_2_text_color=&#8221;#193b7a&#8221; header_2_font_size=&#8221;14px&#8221; header_2_letter_spacing=&#8221;1px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;Rubik|500|||||||&#8221; header_3_font_size=&#8221;38px&#8221; header_3_line_height=&#8221;1.4em&#8221; custom_margin=&#8221;||0px||false|false&#8221; header_2_font_size_tablet=&#8221;42px&#8221; header_2_font_size_phone=&#8221;32px&#8221; header_2_font_size_last_edited=&#8221;off|desktop&#8221; header_3_font_size_tablet=&#8221;28px&#8221; header_3_font_size_phone=&#8221;20px&#8221; header_3_font_size_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Medical Devices<\/h2>\n<h1>From the product idea to certification and successful market launch<\/h1>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.16&#8243; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.17.4&#8243; text_font=&#8221;Manrope||||||||&#8221; text_text_color=&#8221;#6d7c90&#8243; header_font=&#8221;Manrope|600|||||||&#8221; header_font_size=&#8221;29px&#8221; header_line_height=&#8221;1.4em&#8221; header_2_font=&#8221;Rubik|500||on|||||&#8221; header_2_text_color=&#8221;#ff8f00&#8243; header_2_font_size=&#8221;14px&#8221; header_2_letter_spacing=&#8221;1px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;Rubik|500|||||||&#8221; header_3_font_size=&#8221;38px&#8221; header_3_line_height=&#8221;1.4em&#8221; header_2_font_size_tablet=&#8221;42px&#8221; header_2_font_size_phone=&#8221;32px&#8221; header_2_font_size_last_edited=&#8221;off|desktop&#8221; header_3_font_size_tablet=&#8221;28px&#8221; header_3_font_size_phone=&#8221;20px&#8221; header_3_font_size_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Pharma Expertise Consulting helps you develop, manufacture, and <a href=\"\/en\/medical-device-pharmaceutical-development\"><strong>launch medical devices<\/strong><\/a> (<a href=\"\/en\/medical-devices-ce-marking-conformity-assessment\"><strong>conformity assessment procedures \/ regulatory approval \/ CE marking<\/strong><\/a>), promote and position them (<a href=\"\/en\/marketing-sales\"><strong>marketing and sales concepts<\/strong><\/a>), and accompany them through the entire life cycle (quality management system, post-market surveillance, etc.) in accordance with the relevant guidelines of the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32017R0745\">European Medical Device Regulation (<strong>EU MDR<\/strong>)<\/a> or for the US Market <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm\">the Code of Regulations (<strong>CFR)<\/strong> Title 21.<\/a><\/p>\n<p>We take care of sub-areas such as advertising brochures but are also happy to develop the entire product launch (advertising campaign, sales concept, and brand strategy).<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;CTAs&#8221; _builder_version=&#8221;4.16&#8243; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_cta title=&#8221;Marketing &#038; Distribution&#8221; button_url=&#8221;\/en\/marketing-sales&#8221; button_text=&#8221;Learn More&#8221; _builder_version=&#8221;4.17.4&#8243; header_font=&#8221;Manrope|600|||||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_line_height=&#8221;1.2em&#8221; body_font=&#8221;Manrope||||||||&#8221; body_text_color=&#8221;#FFFFFF&#8221; body_line_height=&#8221;2em&#8221; background_color=&#8221;#16918f&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;150deg&#8221; background_color_gradient_stops=&#8221;#16918f 0%|#1bb5b2 100%&#8221; background_color_gradient_start=&#8221;#16918f&#8221; background_color_gradient_end=&#8221;#1bb5b2&#8243; background_image=&#8221;https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png&#8221; background_position=&#8221;bottom_left&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;13px&#8221; button_text_color=&#8221;#ffffff&#8221; button_bg_color=&#8221;RGBA(0,0,0,0)&#8221; button_border_width=&#8221;2px&#8221; button_border_color=&#8221;#FFFFFF&#8221; button_border_radius=&#8221;0px&#8221; button_letter_spacing=&#8221;1px&#8221; button_font=&#8221;Manrope|||on|||||&#8221; button_icon=&#8221;&#x24;||divi||400&#8243; button_icon_color=&#8221;#FFFFFF&#8221; text_orientation=&#8221;left&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; custom_padding_phone=&#8221;|0px||&#8221; custom_padding_last_edited=&#8221;off|desktop&#8221; animation_style=&#8221;zoom&#8221; animation_delay=&#8221;200ms&#8221; animation_intensity_zoom=&#8221;20%&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_vertical=&#8221;90px&#8221; box_shadow_blur=&#8221;160px&#8221; box_shadow_color=&#8221;rgba(0,0,0,0.06)&#8221; box_shadow_style_button=&#8221;preset1&#8243; box_shadow_vertical_button=&#8221;20px&#8221; box_shadow_blur_button=&#8221;30px&#8221; box_shadow_color_button=&#8221;rgba(0,0,0,0.1)&#8221; button_letter_spacing_hover=&#8221;1px&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_text_color__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_border_width__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_border_color__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_border_radius__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover_enabled=&#8221;on&#8221; button_letter_spacing__hover=&#8221;1px&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221;]<\/p>\n<p>We support you from the product launch (medical marketing, advertising measures, and trademark applications) to the selection of the appropriate distribution channel.<\/p>\n<p>[\/et_pb_cta][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_cta title=&#8221;Regulatory Affairs&#8221; button_url=&#8221;\/en\/medical-devices-regulatory-affairs&#8221; button_text=&#8221;Learn More&#8221; _builder_version=&#8221;4.17.4&#8243; header_font=&#8221;Manrope|600|||||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_line_height=&#8221;1.2em&#8221; body_font=&#8221;Manrope||||||||&#8221; body_text_color=&#8221;#FFFFFF&#8221; body_line_height=&#8221;2em&#8221; background_color=&#8221;#16918f&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;150deg&#8221; background_color_gradient_stops=&#8221;#16918f 0%|#1bb5b2 100%&#8221; background_color_gradient_start=&#8221;#16918f&#8221; background_color_gradient_end=&#8221;#1bb5b2&#8243; background_image=&#8221;https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png&#8221; background_position=&#8221;bottom_left&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;13px&#8221; button_text_color=&#8221;#ffffff&#8221; button_bg_color=&#8221;RGBA(0,0,0,0)&#8221; button_border_width=&#8221;2px&#8221; button_border_color=&#8221;#FFFFFF&#8221; button_border_radius=&#8221;0px&#8221; button_letter_spacing=&#8221;1px&#8221; button_font=&#8221;Manrope|||on|||||&#8221; button_icon=&#8221;&#x24;||divi||400&#8243; button_icon_color=&#8221;#FFFFFF&#8221; text_orientation=&#8221;left&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; custom_padding_phone=&#8221;|0px||&#8221; custom_padding_last_edited=&#8221;off|desktop&#8221; animation_style=&#8221;zoom&#8221; animation_delay=&#8221;200ms&#8221; animation_intensity_zoom=&#8221;20%&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_vertical=&#8221;90px&#8221; box_shadow_blur=&#8221;160px&#8221; box_shadow_color=&#8221;rgba(0,0,0,0.06)&#8221; box_shadow_style_button=&#8221;preset1&#8243; box_shadow_vertical_button=&#8221;20px&#8221; box_shadow_blur_button=&#8221;30px&#8221; box_shadow_color_button=&#8221;rgba(0,0,0,0.1)&#8221; button_letter_spacing_hover=&#8221;1px&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_text_color__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_border_width__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_border_color__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_border_radius__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover_enabled=&#8221;on&#8221; button_letter_spacing__hover=&#8221;1px&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221;]<\/p>\n<p>From the regulatory strategy, preparation and submission of technical documentation to the successful FDA approval of your medical device (Premarket Notification 510(k), Premarket Approval PMA, DeNovo).<\/p>\n<p>[\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_cta title=&#8221;Conformity Assessment &#038; CE Marking&#8221; button_url=&#8221;\/en\/medical-devices-ce-marking-conformity-assessment&#8221; button_text=&#8221;Learn More&#8221; _builder_version=&#8221;4.17.4&#8243; header_font=&#8221;Manrope|600|||||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_line_height=&#8221;1.2em&#8221; body_font=&#8221;Manrope||||||||&#8221; body_text_color=&#8221;#FFFFFF&#8221; body_line_height=&#8221;2em&#8221; background_color=&#8221;#16918f&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;150deg&#8221; background_color_gradient_stops=&#8221;#16918f 0%|#1bb5b2 100%&#8221; background_color_gradient_start=&#8221;#16918f&#8221; background_color_gradient_end=&#8221;#1bb5b2&#8243; background_image=&#8221;https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png&#8221; background_position=&#8221;bottom_left&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;13px&#8221; button_text_color=&#8221;#ffffff&#8221; button_bg_color=&#8221;RGBA(0,0,0,0)&#8221; button_border_width=&#8221;2px&#8221; button_border_color=&#8221;#FFFFFF&#8221; button_border_radius=&#8221;0px&#8221; button_letter_spacing=&#8221;1px&#8221; button_font=&#8221;Manrope|||on|||||&#8221; button_icon=&#8221;&#x24;||divi||400&#8243; button_icon_color=&#8221;#FFFFFF&#8221; text_orientation=&#8221;left&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; custom_padding_phone=&#8221;|0px||&#8221; custom_padding_last_edited=&#8221;off|desktop&#8221; animation_style=&#8221;zoom&#8221; animation_delay=&#8221;200ms&#8221; animation_intensity_zoom=&#8221;20%&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_vertical=&#8221;90px&#8221; box_shadow_blur=&#8221;160px&#8221; box_shadow_color=&#8221;rgba(0,0,0,0.06)&#8221; box_shadow_style_button=&#8221;preset1&#8243; box_shadow_vertical_button=&#8221;20px&#8221; box_shadow_blur_button=&#8221;30px&#8221; box_shadow_color_button=&#8221;rgba(0,0,0,0.1)&#8221; button_letter_spacing_hover=&#8221;1px&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_text_color__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_border_width__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_border_color__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_border_radius__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover_enabled=&#8221;on&#8221; button_letter_spacing__hover=&#8221;1px&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221;]<\/p>\n<p>We accompany you from the product classification to the FDA approval (Premarket Notification 510(k), Premarket Approval PMA, DeNovo)\u00a0 for the US Market and to the conformity assessment procedure\/ submission to CE-Marking for the European Market.<\/p>\n<p>[\/et_pb_cta][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_cta title=&#8221;Quality Management System (QMS)&#8221; button_url=&#8221;\/en\/quality-management-system&#8221; button_text=&#8221;Learn More&#8221; _builder_version=&#8221;4.17.4&#8243; header_font=&#8221;Manrope|600|||||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_line_height=&#8221;1.2em&#8221; body_font=&#8221;Manrope||||||||&#8221; body_text_color=&#8221;#FFFFFF&#8221; body_line_height=&#8221;2em&#8221; background_color=&#8221;#16918f&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;150deg&#8221; background_color_gradient_stops=&#8221;#16918f 0%|#1bb5b2 100%&#8221; background_color_gradient_start=&#8221;#16918f&#8221; background_color_gradient_end=&#8221;#1bb5b2&#8243; background_image=&#8221;https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png&#8221; background_position=&#8221;bottom_left&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;13px&#8221; button_text_color=&#8221;#ffffff&#8221; button_bg_color=&#8221;RGBA(0,0,0,0)&#8221; button_border_width=&#8221;2px&#8221; button_border_color=&#8221;#FFFFFF&#8221; button_border_radius=&#8221;0px&#8221; button_letter_spacing=&#8221;1px&#8221; button_font=&#8221;Manrope|||on|||||&#8221; button_icon=&#8221;&#x24;||divi||400&#8243; button_icon_color=&#8221;#FFFFFF&#8221; text_orientation=&#8221;left&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; custom_padding_phone=&#8221;|0px||&#8221; custom_padding_last_edited=&#8221;off|desktop&#8221; animation_style=&#8221;zoom&#8221; animation_delay=&#8221;200ms&#8221; animation_intensity_zoom=&#8221;20%&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_vertical=&#8221;90px&#8221; box_shadow_blur=&#8221;160px&#8221; box_shadow_color=&#8221;rgba(0,0,0,0.06)&#8221; box_shadow_style_button=&#8221;preset1&#8243; box_shadow_vertical_button=&#8221;20px&#8221; box_shadow_blur_button=&#8221;30px&#8221; box_shadow_color_button=&#8221;rgba(0,0,0,0.1)&#8221; button_letter_spacing_hover=&#8221;1px&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_text_color__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_border_width__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_border_color__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_border_radius__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover_enabled=&#8221;on&#8221; button_letter_spacing__hover=&#8221;1px&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221;]<\/p>\n<p>Our services include the implementation and maintenance of quality management systems (QMS) that conform to the FDA Quality System Regulation (21 CFR 820) and the international standard ISO 13485 to ensure the safety and performance of medical devices on the market.<\/p>\n<p>[\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_cta title=&#8221;Clinical Evaluation&#8221; button_url=&#8221;\/en\/clinical-evaluation&#8221; button_text=&#8221;Learn More&#8221; _builder_version=&#8221;4.17.4&#8243; header_font=&#8221;Manrope|600|||||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_line_height=&#8221;1.2em&#8221; body_font=&#8221;Manrope||||||||&#8221; body_text_color=&#8221;#FFFFFF&#8221; body_line_height=&#8221;2em&#8221; background_color=&#8221;#16918f&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;150deg&#8221; background_color_gradient_stops=&#8221;#16918f 0%|#1bb5b2 100%&#8221; background_color_gradient_start=&#8221;#16918f&#8221; background_color_gradient_end=&#8221;#1bb5b2&#8243; background_image=&#8221;https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png&#8221; background_position=&#8221;bottom_left&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;13px&#8221; button_text_color=&#8221;#ffffff&#8221; button_bg_color=&#8221;RGBA(0,0,0,0)&#8221; button_border_width=&#8221;2px&#8221; button_border_color=&#8221;#FFFFFF&#8221; button_border_radius=&#8221;0px&#8221; button_letter_spacing=&#8221;1px&#8221; button_font=&#8221;Manrope|||on|||||&#8221; button_icon=&#8221;&#x24;||divi||400&#8243; button_icon_color=&#8221;#FFFFFF&#8221; text_orientation=&#8221;left&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; custom_padding_phone=&#8221;|0px||&#8221; custom_padding_last_edited=&#8221;off|desktop&#8221; animation_style=&#8221;zoom&#8221; animation_delay=&#8221;200ms&#8221; animation_intensity_zoom=&#8221;20%&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_vertical=&#8221;90px&#8221; box_shadow_blur=&#8221;160px&#8221; box_shadow_color=&#8221;rgba(0,0,0,0.06)&#8221; box_shadow_style_button=&#8221;preset1&#8243; box_shadow_vertical_button=&#8221;20px&#8221; box_shadow_blur_button=&#8221;30px&#8221; box_shadow_color_button=&#8221;rgba(0,0,0,0.1)&#8221; button_letter_spacing_hover=&#8221;1px&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_text_color__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_border_width__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_border_color__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_border_radius__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover_enabled=&#8221;on&#8221; button_letter_spacing__hover=&#8221;1px&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221;]<\/p>\n<p>We conduct clinical evaluations using literature data or new in vitro or in vivo data or by conducting a clinical study according to ISO 14155:2011, guideline 2020-16 MDCG.<\/p>\n<p>[\/et_pb_cta][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_cta title=&#8221;Medical Device Safety&#8221; button_url=&#8221;\/medizinproduktesicherheit&#8221; button_text=&#8221;Learn More&#8221; _builder_version=&#8221;4.17.4&#8243; header_font=&#8221;Manrope|600|||||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_line_height=&#8221;1.2em&#8221; body_font=&#8221;Manrope||||||||&#8221; body_text_color=&#8221;#FFFFFF&#8221; body_line_height=&#8221;2em&#8221; background_color=&#8221;#16918f&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;150deg&#8221; background_color_gradient_stops=&#8221;#16918f 0%|#1bb5b2 100%&#8221; background_color_gradient_start=&#8221;#16918f&#8221; background_color_gradient_end=&#8221;#1bb5b2&#8243; background_image=&#8221;https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png&#8221; background_position=&#8221;bottom_left&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;13px&#8221; button_text_color=&#8221;#ffffff&#8221; button_bg_color=&#8221;RGBA(0,0,0,0)&#8221; button_border_width=&#8221;2px&#8221; button_border_color=&#8221;#FFFFFF&#8221; button_border_radius=&#8221;0px&#8221; button_letter_spacing=&#8221;1px&#8221; button_font=&#8221;Manrope|||on|||||&#8221; button_icon=&#8221;&#x24;||divi||400&#8243; button_icon_color=&#8221;#FFFFFF&#8221; text_orientation=&#8221;left&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; custom_padding_phone=&#8221;|0px||&#8221; custom_padding_last_edited=&#8221;off|desktop&#8221; animation_style=&#8221;zoom&#8221; animation_delay=&#8221;200ms&#8221; animation_intensity_zoom=&#8221;20%&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_vertical=&#8221;90px&#8221; box_shadow_blur=&#8221;160px&#8221; box_shadow_color=&#8221;rgba(0,0,0,0.06)&#8221; box_shadow_style_button=&#8221;preset1&#8243; box_shadow_vertical_button=&#8221;20px&#8221; box_shadow_blur_button=&#8221;30px&#8221; box_shadow_color_button=&#8221;rgba(0,0,0,0.1)&#8221; button_letter_spacing_hover=&#8221;1px&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_text_color__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_border_width__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_border_color__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_border_radius__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover_enabled=&#8221;on&#8221; button_letter_spacing__hover=&#8221;1px&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221;]<\/p>\n<p>We can assist you with the establishment of a vigilance system, adverse event reporting FDA requirements\u00a0 (21 CFR 803 Medical Device Reporting), post-market surveillance (21 CFR 806), post-market clinical follow-up studies for the US market and accordingly for the EU market with the ISO 13485.<\/p>\n<p>[\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_margin=&#8221;||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_cta title=&#8221;Pharmaceutical Development&#8221; button_url=&#8221;\/en\/medical-device-pharmaceutical-development&#8221; button_text=&#8221;Learn More&#8221; _builder_version=&#8221;4.17.4&#8243; header_font=&#8221;Manrope|600|||||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_line_height=&#8221;1.2em&#8221; body_font=&#8221;Manrope||||||||&#8221; body_text_color=&#8221;#FFFFFF&#8221; body_line_height=&#8221;2em&#8221; background_color=&#8221;#16918f&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;150deg&#8221; background_color_gradient_stops=&#8221;#16918f 0%|#1bb5b2 100%&#8221; background_color_gradient_start=&#8221;#16918f&#8221; background_color_gradient_end=&#8221;#1bb5b2&#8243; background_image=&#8221;https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png&#8221; background_position=&#8221;bottom_left&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;13px&#8221; button_text_color=&#8221;#ffffff&#8221; button_bg_color=&#8221;RGBA(0,0,0,0)&#8221; button_border_width=&#8221;2px&#8221; button_border_color=&#8221;#FFFFFF&#8221; button_border_radius=&#8221;0px&#8221; button_letter_spacing=&#8221;1px&#8221; button_font=&#8221;Manrope|||on|||||&#8221; button_icon=&#8221;&#x24;||divi||400&#8243; button_icon_color=&#8221;#FFFFFF&#8221; text_orientation=&#8221;left&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; custom_padding_phone=&#8221;|0px||&#8221; custom_padding_last_edited=&#8221;off|desktop&#8221; animation_style=&#8221;zoom&#8221; animation_delay=&#8221;200ms&#8221; animation_intensity_zoom=&#8221;20%&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_vertical=&#8221;90px&#8221; box_shadow_blur=&#8221;160px&#8221; box_shadow_color=&#8221;rgba(0,0,0,0.06)&#8221; box_shadow_style_button=&#8221;preset1&#8243; box_shadow_vertical_button=&#8221;20px&#8221; box_shadow_blur_button=&#8221;30px&#8221; box_shadow_color_button=&#8221;rgba(0,0,0,0.1)&#8221; button_letter_spacing_hover=&#8221;1px&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_text_color__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_border_width__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_border_color__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_border_radius__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover_enabled=&#8221;on&#8221; button_letter_spacing__hover=&#8221;1px&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221;]<\/p>\n<p>We accompany you from the product idea to the galenic development\/formulation to the contract manufacturing of your medical device.<\/p>\n<p>[\/et_pb_cta][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_cta title=&#8221;In- &#038; Out-Licensing&#8221; button_url=&#8221;\/en\/in-and-outlicensing&#8221; button_text=&#8221;Learn More&#8221; _builder_version=&#8221;4.17.4&#8243; header_font=&#8221;Manrope|600|||||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_line_height=&#8221;1.2em&#8221; body_font=&#8221;Manrope||||||||&#8221; body_text_color=&#8221;#FFFFFF&#8221; body_line_height=&#8221;2em&#8221; background_color=&#8221;#16918f&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;150deg&#8221; background_color_gradient_stops=&#8221;#16918f 0%|#1bb5b2 100%&#8221; background_color_gradient_start=&#8221;#16918f&#8221; background_color_gradient_end=&#8221;#1bb5b2&#8243; background_image=&#8221;https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png&#8221; background_position=&#8221;bottom_left&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;13px&#8221; button_text_color=&#8221;#ffffff&#8221; button_bg_color=&#8221;RGBA(0,0,0,0)&#8221; button_border_width=&#8221;2px&#8221; button_border_color=&#8221;#FFFFFF&#8221; button_border_radius=&#8221;0px&#8221; button_letter_spacing=&#8221;1px&#8221; button_font=&#8221;Manrope|||on|||||&#8221; button_icon=&#8221;&#x24;||divi||400&#8243; button_icon_color=&#8221;#FFFFFF&#8221; text_orientation=&#8221;left&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; custom_padding_phone=&#8221;|0px||&#8221; custom_padding_last_edited=&#8221;off|desktop&#8221; animation_style=&#8221;zoom&#8221; animation_delay=&#8221;200ms&#8221; animation_intensity_zoom=&#8221;20%&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_vertical=&#8221;90px&#8221; box_shadow_blur=&#8221;160px&#8221; box_shadow_color=&#8221;rgba(0,0,0,0.06)&#8221; box_shadow_style_button=&#8221;preset1&#8243; box_shadow_vertical_button=&#8221;20px&#8221; box_shadow_blur_button=&#8221;30px&#8221; box_shadow_color_button=&#8221;rgba(0,0,0,0.1)&#8221; button_letter_spacing_hover=&#8221;1px&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_text_color__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_border_width__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_border_color__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_border_radius__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover_enabled=&#8221;on&#8221; button_letter_spacing__hover=&#8221;1px&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221;]<\/p>\n<p>We help you increase sales through national and international marketing of licensing and distribution rights as well as acquisition of medical products.<\/p>\n<p>[\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_2,1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_margin=&#8221;||60px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_cta title=&#8221;Import &#038; Export &#8221; button_url=&#8221;\/en\/import-export&#8221; button_text=&#8221;Learn More&#8221; _builder_version=&#8221;4.17.4&#8243; header_font=&#8221;Manrope|600|||||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_line_height=&#8221;1.2em&#8221; body_font=&#8221;Manrope||||||||&#8221; body_text_color=&#8221;#FFFFFF&#8221; body_line_height=&#8221;2em&#8221; background_color=&#8221;#16918f&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;150deg&#8221; background_color_gradient_stops=&#8221;#16918f 0%|#1bb5b2 100%&#8221; background_color_gradient_start=&#8221;#16918f&#8221; background_color_gradient_end=&#8221;#1bb5b2&#8243; background_image=&#8221;https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png&#8221; background_position=&#8221;bottom_left&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;13px&#8221; button_text_color=&#8221;#ffffff&#8221; button_bg_color=&#8221;RGBA(0,0,0,0)&#8221; button_border_width=&#8221;2px&#8221; button_border_color=&#8221;#FFFFFF&#8221; button_border_radius=&#8221;0px&#8221; button_letter_spacing=&#8221;1px&#8221; button_font=&#8221;Manrope|||on|||||&#8221; button_icon=&#8221;&#x24;||divi||400&#8243; button_icon_color=&#8221;#FFFFFF&#8221; text_orientation=&#8221;left&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;|||&#8221; custom_padding_phone=&#8221;|0px||&#8221; custom_padding_last_edited=&#8221;off|desktop&#8221; animation_style=&#8221;zoom&#8221; animation_delay=&#8221;200ms&#8221; animation_intensity_zoom=&#8221;20%&#8221; box_shadow_style=&#8221;preset1&#8243; box_shadow_vertical=&#8221;90px&#8221; box_shadow_blur=&#8221;160px&#8221; box_shadow_color=&#8221;rgba(0,0,0,0.06)&#8221; box_shadow_style_button=&#8221;preset1&#8243; box_shadow_vertical_button=&#8221;20px&#8221; box_shadow_blur_button=&#8221;30px&#8221; box_shadow_color_button=&#8221;rgba(0,0,0,0.1)&#8221; button_letter_spacing_hover=&#8221;1px&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_text_color__hover_enabled=&#8221;off&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_border_width__hover_enabled=&#8221;off&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_border_color__hover_enabled=&#8221;off&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_border_radius__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover_enabled=&#8221;on&#8221; button_letter_spacing__hover=&#8221;1px&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221;]<\/p>\n<p>We manage fast and uncomplicated implementation of regulatory and customs requirements for the import and export of medical devices.<\/p>\n<p>[\/et_pb_cta][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical Devices From the product idea to certification and successful market launchPharma Expertise Consulting helps you develop, manufacture, and launch medical devices (conformity assessment procedures \/ regulatory approval \/ CE marking), promote and position them (marketing and sales concepts), and accompany them through the entire life cycle (quality management system, post-market surveillance, etc.) in accordance [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"<p>[et_pb_section fb_built=\"1\" fullwidth=\"on\" _builder_version=\"4.10.7\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_fullwidth_image src=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/10\/top_pharma-medizinprodukte-min.jpg\" alt=\"Pharma & Medizinprodukte\" title_text=\"Medizinprodukte\" _builder_version=\"4.11.4\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=\"1\" admin_label=\"About\" _builder_version=\"3.22\" global_colors_info=\"{}\"][et_pb_row _builder_version=\"4.10.7\" custom_margin=\"||0px||false|false\" custom_padding=\"0px||0px||false|false\" locked=\"off\" global_colors_info=\"{}\"][et_pb_column type=\"4_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_text _builder_version=\"4.14.2\" text_font=\"Manrope||||||||\" text_line_height=\"2em\" header_font=\"Manrope|600|||||||\" header_text_color=\"#20292f\" header_font_size=\"26px\" header_line_height=\"1.3em\" header_2_font=\"Manrope|600||on|||||\" header_2_text_color=\"#193b7a\" header_2_font_size=\"14px\" header_2_letter_spacing=\"1px\" header_2_line_height=\"1.5em\" header_3_font=\"Rubik|500|||||||\" header_3_font_size=\"38px\" header_3_line_height=\"1.4em\" custom_margin=\"||0px||false|false\" header_2_font_size_tablet=\"42px\" header_2_font_size_phone=\"32px\" header_2_font_size_last_edited=\"off|desktop\" header_3_font_size_tablet=\"28px\" header_3_font_size_phone=\"20px\" header_3_font_size_last_edited=\"on|phone\" locked=\"off\" global_colors_info=\"{}\"]<\/p><h2>Medizinprodukte<\/h2><h1>Von der Produktidee \u00fcber die Zertifizierung bis hin zur erfolgreichen Markteinf\u00fchrung<\/h1><p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\"4.11.3\" custom_margin=\"0px||0px||false|false\" custom_padding=\"0px||0px||false|false\" locked=\"off\" global_colors_info=\"{}\"][et_pb_column type=\"4_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_text _builder_version=\"4.14.2\" text_font=\"Manrope||||||||\" text_text_color=\"#6d7c90\" header_font=\"Manrope|600|||||||\" header_font_size=\"29px\" header_line_height=\"1.4em\" header_2_font=\"Rubik|500||on|||||\" header_2_text_color=\"#ff8f00\" header_2_font_size=\"14px\" header_2_letter_spacing=\"1px\" header_2_line_height=\"1.5em\" header_3_font=\"Rubik|500|||||||\" header_3_font_size=\"38px\" header_3_line_height=\"1.4em\" header_2_font_size_tablet=\"42px\" header_2_font_size_phone=\"32px\" header_2_font_size_last_edited=\"off|desktop\" header_3_font_size_tablet=\"28px\" header_3_font_size_phone=\"20px\" header_3_font_size_last_edited=\"on|phone\" locked=\"off\" global_colors_info=\"{}\"]<\/p><p>Pharma Expertise Consulting hilft Ihnen, <a title=\"Entwicklung Medizinprodukte\" href=\"\/medizinprodukte-pharmazeutische-entwicklung\"><strong>Medizinprodukte zu entwickeln<\/strong><\/a>, <strong>herzustellen<\/strong>, <strong>auf den Markt zu bringen<\/strong> (<a title=\"Zulassung Medizinprodukte\" href=\"\/medizinprodukte-konformitaetsbewertung-ce-kennzeichnung\"><strong>Konformit\u00e4tsbewertungsverfahren\u00a0<\/strong>\/\u00a0<strong>beh\u00f6rdliche Zulassung\u00a0<\/strong>\/\u00a0<strong>CE-Kennzeichnung<\/strong><\/a>), zu <strong>bewerben<\/strong> und zu <strong>positionieren<\/strong> (<a title=\"Marketing- und Vertriebskonzepte\" href=\"\/medizinprodukte-marketing-vertrieb\"><strong>Marketing- und Vertriebskonzepte<\/strong><\/a>) sowie \u00fcber den gesamten Lebenszyklus zu begleiten (<a title=\"Qualit\u00e4tsmanagementsystem Medizinprodukte\" href=\"\/medizinprodukte-qualitaetsmanagementsystem\"><strong>Qualit\u00e4tsmanagementsystem<\/strong><\/a>, <a title=\"Post Market Surveillance\" href=\"\/medizinproduktesicherheit\"><strong>Post-Market Surveillance<\/strong><\/a> etc.) \u2013 gem\u00e4\u00df den entsprechenden <strong>Richtlinien der Medical Device Regulation (<a title=\"Medical Device Regulation MDR\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/?uri=CELEX%3A32017R0745\" target=\"_blank\" rel=\"noopener\">MDR<\/a>), des Medizinproduktegesetzes (<a title=\"Medizinproduktegesetz MPG\" href=\"https:\/\/www.gesetze-im-internet.de\/mpg\/\" target=\"_blank\" rel=\"noopener\">MPG<\/a>), des Heilmittelwerbegesetzes (<a title=\"Heilmittelwerbegesetz HWG\" href=\"https:\/\/www.gesetze-im-internet.de\/heilmwerbg\/BJNR006049965.html\" target=\"_blank\" rel=\"noopener\">HWG<\/a>)<\/strong> etc.<\/p><p>Dabei \u00fcbernehmen wir Teilbereiche wie Werbebrosch\u00fcren, entwickeln aber auch gerne die gesamte Produkteinf\u00fchrung (Werbekampagne, Vertriebskonzept, Markenstrategie).<\/p><p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\"1\" admin_label=\"CTAs\" _builder_version=\"4.10.7\" custom_margin=\"0px||0px||false|false\" custom_padding=\"0px||0px||false|false\" global_colors_info=\"{}\"][et_pb_row column_structure=\"1_2,1_2\" _builder_version=\"3.25\" global_colors_info=\"{}\"][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_cta title=\"Marketing & Vertrieb\" button_url=\"\/medizinprodukte-marketing-vertrieb\" button_text=\"Weitere Infos\" _builder_version=\"4.14.2\" header_font=\"Manrope|600|||||||\" header_text_color=\"#FFFFFF\" header_line_height=\"1.2em\" body_font=\"Manrope||||||||\" body_text_color=\"#FFFFFF\" body_line_height=\"2em\" background_color=\"#16918f\" use_background_color_gradient=\"on\" background_color_gradient_start=\"#16918f\" background_color_gradient_end=\"#1bb5b2\" background_color_gradient_direction=\"150deg\" background_image=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png\" background_position=\"bottom_left\" custom_button=\"on\" button_text_size=\"13px\" button_text_color=\"#ffffff\" button_bg_color=\"RGBA(0,0,0,0)\" button_border_width=\"2px\" button_border_color=\"#FFFFFF\" button_border_radius=\"0px\" button_letter_spacing=\"1px\" button_font=\"Manrope|||on|||||\" button_icon=\"$||divi||400\" button_icon_color=\"#FFFFFF\" text_orientation=\"left\" custom_margin=\"|||\" custom_padding=\"|||\" custom_padding_phone=\"|0px||\" custom_padding_last_edited=\"off|desktop\" animation_style=\"zoom\" animation_delay=\"200ms\" animation_intensity_zoom=\"20%\" box_shadow_style=\"preset1\" box_shadow_vertical=\"90px\" box_shadow_blur=\"160px\" box_shadow_color=\"rgba(0,0,0,0.06)\" box_shadow_style_button=\"preset1\" box_shadow_vertical_button=\"20px\" box_shadow_blur_button=\"30px\" box_shadow_color_button=\"rgba(0,0,0,0.1)\" button_letter_spacing_hover=\"1px\" locked=\"off\" global_colors_info=\"{}\" button_text_size__hover_enabled=\"off\" button_one_text_size__hover_enabled=\"off\" button_two_text_size__hover_enabled=\"off\" button_text_color__hover_enabled=\"off\" button_one_text_color__hover_enabled=\"off\" button_two_text_color__hover_enabled=\"off\" button_border_width__hover_enabled=\"off\" button_one_border_width__hover_enabled=\"off\" button_two_border_width__hover_enabled=\"off\" button_border_color__hover_enabled=\"off\" button_one_border_color__hover_enabled=\"off\" button_two_border_color__hover_enabled=\"off\" button_border_radius__hover_enabled=\"off\" button_one_border_radius__hover_enabled=\"off\" button_two_border_radius__hover_enabled=\"off\" button_letter_spacing__hover_enabled=\"on\" button_letter_spacing__hover=\"1px\" button_one_letter_spacing__hover_enabled=\"off\" button_two_letter_spacing__hover_enabled=\"off\" button_bg_color__hover_enabled=\"off\" button_one_bg_color__hover_enabled=\"off\" button_two_bg_color__hover_enabled=\"off\"]<\/p><p>Wir unterst\u00fctzen Sie von der Produkteinf\u00fchrung (Medical Marketing, Werbema\u00dfnahmen, Markenanmeldungen) bis zur Selektion des geeigneten Vertriebskanals.<\/p><p>[\/et_pb_cta][\/et_pb_column][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_cta title=\"Regulatory Affairs\" button_url=\"\/medizinprodukte-regulatory-affairs\" button_text=\"Weitere Infos\" _builder_version=\"4.14.2\" header_font=\"Manrope|600|||||||\" header_text_color=\"#FFFFFF\" header_line_height=\"1.2em\" body_font=\"Manrope||||||||\" body_text_color=\"#FFFFFF\" body_line_height=\"2em\" background_color=\"#16918f\" use_background_color_gradient=\"on\" background_color_gradient_start=\"#16918f\" background_color_gradient_end=\"#1bb5b2\" background_color_gradient_direction=\"150deg\" background_image=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png\" background_position=\"bottom_left\" custom_button=\"on\" button_text_size=\"13px\" button_text_color=\"#ffffff\" button_bg_color=\"RGBA(0,0,0,0)\" button_border_width=\"2px\" button_border_color=\"#FFFFFF\" button_border_radius=\"0px\" button_letter_spacing=\"1px\" button_font=\"Manrope|||on|||||\" button_icon=\"$||divi||400\" button_icon_color=\"#FFFFFF\" text_orientation=\"left\" custom_margin=\"|||\" custom_padding=\"|||\" custom_padding_phone=\"|0px||\" custom_padding_last_edited=\"off|desktop\" animation_style=\"zoom\" animation_delay=\"200ms\" animation_intensity_zoom=\"20%\" box_shadow_style=\"preset1\" box_shadow_vertical=\"90px\" box_shadow_blur=\"160px\" box_shadow_color=\"rgba(0,0,0,0.06)\" box_shadow_style_button=\"preset1\" box_shadow_vertical_button=\"20px\" box_shadow_blur_button=\"30px\" box_shadow_color_button=\"rgba(0,0,0,0.1)\" button_letter_spacing_hover=\"1px\" locked=\"off\" global_colors_info=\"{}\" button_text_size__hover_enabled=\"off\" button_one_text_size__hover_enabled=\"off\" button_two_text_size__hover_enabled=\"off\" button_text_color__hover_enabled=\"off\" button_one_text_color__hover_enabled=\"off\" button_two_text_color__hover_enabled=\"off\" button_border_width__hover_enabled=\"off\" button_one_border_width__hover_enabled=\"off\" button_two_border_width__hover_enabled=\"off\" button_border_color__hover_enabled=\"off\" button_one_border_color__hover_enabled=\"off\" button_two_border_color__hover_enabled=\"off\" button_border_radius__hover_enabled=\"off\" button_one_border_radius__hover_enabled=\"off\" button_two_border_radius__hover_enabled=\"off\" button_letter_spacing__hover_enabled=\"on\" button_letter_spacing__hover=\"1px\" button_one_letter_spacing__hover_enabled=\"off\" button_two_letter_spacing__hover_enabled=\"off\" button_bg_color__hover_enabled=\"off\" button_one_bg_color__hover_enabled=\"off\" button_two_bg_color__hover_enabled=\"off\"]<\/p><p>Von der Zulassungsstrategie \u00fcber die Erstellung der technischen Dokumentation zur erfolgreichen Zertifizierung Ihres Medizinproduktes.<\/p><p>[\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\"1_2,1_2\" _builder_version=\"3.25\" global_colors_info=\"{}\"][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_cta title=\"Konformit\u00e4tsbewertung & CE-Kennzeichnung\" button_url=\"\/medizinprodukte-konformitaetsbewertung-ce-kennzeichnung\" button_text=\"Weitere Infos\" _builder_version=\"4.14.2\" header_font=\"Manrope|600|||||||\" header_text_color=\"#FFFFFF\" header_line_height=\"1.2em\" body_font=\"Manrope||||||||\" body_text_color=\"#FFFFFF\" body_line_height=\"2em\" background_color=\"#16918f\" use_background_color_gradient=\"on\" background_color_gradient_start=\"#16918f\" background_color_gradient_end=\"#1bb5b2\" background_color_gradient_direction=\"150deg\" background_image=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png\" background_position=\"bottom_left\" custom_button=\"on\" button_text_size=\"13px\" button_text_color=\"#ffffff\" button_bg_color=\"RGBA(0,0,0,0)\" button_border_width=\"2px\" button_border_color=\"#FFFFFF\" button_border_radius=\"0px\" button_letter_spacing=\"1px\" button_font=\"Manrope|||on|||||\" button_icon=\"$||divi||400\" button_icon_color=\"#FFFFFF\" text_orientation=\"left\" custom_margin=\"|||\" custom_padding=\"|||\" custom_padding_phone=\"|0px||\" custom_padding_last_edited=\"off|desktop\" animation_style=\"zoom\" animation_delay=\"200ms\" animation_intensity_zoom=\"20%\" box_shadow_style=\"preset1\" box_shadow_vertical=\"90px\" box_shadow_blur=\"160px\" box_shadow_color=\"rgba(0,0,0,0.06)\" box_shadow_style_button=\"preset1\" box_shadow_vertical_button=\"20px\" box_shadow_blur_button=\"30px\" box_shadow_color_button=\"rgba(0,0,0,0.1)\" button_letter_spacing_hover=\"1px\" locked=\"off\" global_colors_info=\"{}\" button_text_size__hover_enabled=\"off\" button_one_text_size__hover_enabled=\"off\" button_two_text_size__hover_enabled=\"off\" button_text_color__hover_enabled=\"off\" button_one_text_color__hover_enabled=\"off\" button_two_text_color__hover_enabled=\"off\" button_border_width__hover_enabled=\"off\" button_one_border_width__hover_enabled=\"off\" button_two_border_width__hover_enabled=\"off\" button_border_color__hover_enabled=\"off\" button_one_border_color__hover_enabled=\"off\" button_two_border_color__hover_enabled=\"off\" button_border_radius__hover_enabled=\"off\" button_one_border_radius__hover_enabled=\"off\" button_two_border_radius__hover_enabled=\"off\" button_letter_spacing__hover_enabled=\"on\" button_letter_spacing__hover=\"1px\" button_one_letter_spacing__hover_enabled=\"off\" button_two_letter_spacing__hover_enabled=\"off\" button_bg_color__hover_enabled=\"off\" button_one_bg_color__hover_enabled=\"off\" button_two_bg_color__hover_enabled=\"off\"]<\/p><p>Von der Produktklassifizierung \u00fcber das Konformit\u00e4tsbewertungsverfahren zur CE-Kennzeichnung.<\/p><p>[\/et_pb_cta][\/et_pb_column][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_cta title=\"Qualit\u00e4tsmanagement (ISO)\" button_url=\"\/medizinprodukte-qualitaetsmanagementsystem\" button_text=\"Weitere Infos\" _builder_version=\"4.14.2\" header_font=\"Manrope|600|||||||\" header_text_color=\"#FFFFFF\" header_line_height=\"1.2em\" body_font=\"Manrope||||||||\" body_text_color=\"#FFFFFF\" body_line_height=\"2em\" background_color=\"#16918f\" use_background_color_gradient=\"on\" background_color_gradient_start=\"#16918f\" background_color_gradient_end=\"#1bb5b2\" background_color_gradient_direction=\"150deg\" background_image=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png\" background_position=\"bottom_left\" custom_button=\"on\" button_text_size=\"13px\" button_text_color=\"#ffffff\" button_bg_color=\"RGBA(0,0,0,0)\" button_border_width=\"2px\" button_border_color=\"#FFFFFF\" button_border_radius=\"0px\" button_letter_spacing=\"1px\" button_font=\"Manrope|||on|||||\" button_icon=\"$||divi||400\" button_icon_color=\"#FFFFFF\" text_orientation=\"left\" custom_margin=\"|||\" custom_padding=\"|||\" custom_padding_phone=\"|0px||\" custom_padding_last_edited=\"off|desktop\" animation_style=\"zoom\" animation_delay=\"200ms\" animation_intensity_zoom=\"20%\" box_shadow_style=\"preset1\" box_shadow_vertical=\"90px\" box_shadow_blur=\"160px\" box_shadow_color=\"rgba(0,0,0,0.06)\" box_shadow_style_button=\"preset1\" box_shadow_vertical_button=\"20px\" box_shadow_blur_button=\"30px\" box_shadow_color_button=\"rgba(0,0,0,0.1)\" button_letter_spacing_hover=\"1px\" locked=\"off\" global_colors_info=\"{}\" button_text_size__hover_enabled=\"off\" button_one_text_size__hover_enabled=\"off\" button_two_text_size__hover_enabled=\"off\" button_text_color__hover_enabled=\"off\" button_one_text_color__hover_enabled=\"off\" button_two_text_color__hover_enabled=\"off\" button_border_width__hover_enabled=\"off\" button_one_border_width__hover_enabled=\"off\" button_two_border_width__hover_enabled=\"off\" button_border_color__hover_enabled=\"off\" button_one_border_color__hover_enabled=\"off\" button_two_border_color__hover_enabled=\"off\" button_border_radius__hover_enabled=\"off\" button_one_border_radius__hover_enabled=\"off\" button_two_border_radius__hover_enabled=\"off\" button_letter_spacing__hover_enabled=\"on\" button_letter_spacing__hover=\"1px\" button_one_letter_spacing__hover_enabled=\"off\" button_two_letter_spacing__hover_enabled=\"off\" button_bg_color__hover_enabled=\"off\" button_one_bg_color__hover_enabled=\"off\" button_two_bg_color__hover_enabled=\"off\"]<\/p><p>Unsere Services umfassen u. a. die Errichtung und Pflege von Qualit\u00e4tsmanagementsystemen (QMS) nach Norm DIN EN ISO 13485:201 etc., Zertifizierungsaudits, Audits und Selbstinspektionen.<\/p><p>[\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\"1_2,1_2\" _builder_version=\"3.25\" global_colors_info=\"{}\"][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_cta title=\"Klinische Bewertung \" button_url=\"\/medizinprodukte-klinische-bewertung\" button_text=\"Weitere Infos\" _builder_version=\"4.14.2\" header_font=\"Manrope|600|||||||\" header_text_color=\"#FFFFFF\" header_line_height=\"1.2em\" body_font=\"Manrope||||||||\" body_text_color=\"#FFFFFF\" body_line_height=\"2em\" background_color=\"#16918f\" use_background_color_gradient=\"on\" background_color_gradient_start=\"#16918f\" background_color_gradient_end=\"#1bb5b2\" background_color_gradient_direction=\"150deg\" background_image=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png\" background_position=\"bottom_left\" custom_button=\"on\" button_text_size=\"13px\" button_text_color=\"#ffffff\" button_bg_color=\"RGBA(0,0,0,0)\" button_border_width=\"2px\" button_border_color=\"#FFFFFF\" button_border_radius=\"0px\" button_letter_spacing=\"1px\" button_font=\"Manrope|||on|||||\" button_icon=\"$||divi||400\" button_icon_color=\"#FFFFFF\" text_orientation=\"left\" custom_margin=\"|||\" custom_padding=\"|||\" custom_padding_phone=\"|0px||\" custom_padding_last_edited=\"off|desktop\" animation_style=\"zoom\" animation_delay=\"200ms\" animation_intensity_zoom=\"20%\" box_shadow_style=\"preset1\" box_shadow_vertical=\"90px\" box_shadow_blur=\"160px\" box_shadow_color=\"rgba(0,0,0,0.06)\" box_shadow_style_button=\"preset1\" box_shadow_vertical_button=\"20px\" box_shadow_blur_button=\"30px\" box_shadow_color_button=\"rgba(0,0,0,0.1)\" button_letter_spacing_hover=\"1px\" locked=\"off\" global_colors_info=\"{}\" button_text_size__hover_enabled=\"off\" button_one_text_size__hover_enabled=\"off\" button_two_text_size__hover_enabled=\"off\" button_text_color__hover_enabled=\"off\" button_one_text_color__hover_enabled=\"off\" button_two_text_color__hover_enabled=\"off\" button_border_width__hover_enabled=\"off\" button_one_border_width__hover_enabled=\"off\" button_two_border_width__hover_enabled=\"off\" button_border_color__hover_enabled=\"off\" button_one_border_color__hover_enabled=\"off\" button_two_border_color__hover_enabled=\"off\" button_border_radius__hover_enabled=\"off\" button_one_border_radius__hover_enabled=\"off\" button_two_border_radius__hover_enabled=\"off\" button_letter_spacing__hover_enabled=\"on\" button_letter_spacing__hover=\"1px\" button_one_letter_spacing__hover_enabled=\"off\" button_two_letter_spacing__hover_enabled=\"off\" button_bg_color__hover_enabled=\"off\" button_one_bg_color__hover_enabled=\"off\" button_two_bg_color__hover_enabled=\"off\"]<\/p><p>Durchf\u00fchrung der klinischen Bewertung durch Literaturdaten, neue In-vitro- oder In-vivo-Daten; Durchf\u00fchrung einer klinischen Studie gem\u00e4\u00df DIN EN ISO 14155:2011, Leitlinie 2020-16 MDCG etc.<\/p><p>[\/et_pb_cta][\/et_pb_column][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_cta title=\"Medizinprodukte-Sicherheit\" button_url=\"\/medizinproduktesicherheit\" button_text=\"Weitere Infos\" _builder_version=\"4.14.2\" header_font=\"Manrope|600|||||||\" header_text_color=\"#FFFFFF\" header_line_height=\"1.2em\" body_font=\"Manrope||||||||\" body_text_color=\"#FFFFFF\" body_line_height=\"2em\" background_color=\"#16918f\" use_background_color_gradient=\"on\" background_color_gradient_start=\"#16918f\" background_color_gradient_end=\"#1bb5b2\" background_color_gradient_direction=\"150deg\" background_image=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png\" background_position=\"bottom_left\" custom_button=\"on\" button_text_size=\"13px\" button_text_color=\"#ffffff\" button_bg_color=\"RGBA(0,0,0,0)\" button_border_width=\"2px\" button_border_color=\"#FFFFFF\" button_border_radius=\"0px\" button_letter_spacing=\"1px\" button_font=\"Manrope|||on|||||\" button_icon=\"$||divi||400\" button_icon_color=\"#FFFFFF\" text_orientation=\"left\" custom_margin=\"|||\" custom_padding=\"|||\" custom_padding_phone=\"|0px||\" custom_padding_last_edited=\"off|desktop\" animation_style=\"zoom\" animation_delay=\"200ms\" animation_intensity_zoom=\"20%\" box_shadow_style=\"preset1\" box_shadow_vertical=\"90px\" box_shadow_blur=\"160px\" box_shadow_color=\"rgba(0,0,0,0.06)\" box_shadow_style_button=\"preset1\" box_shadow_vertical_button=\"20px\" box_shadow_blur_button=\"30px\" box_shadow_color_button=\"rgba(0,0,0,0.1)\" button_letter_spacing_hover=\"1px\" locked=\"off\" global_colors_info=\"{}\" button_text_size__hover_enabled=\"off\" button_one_text_size__hover_enabled=\"off\" button_two_text_size__hover_enabled=\"off\" button_text_color__hover_enabled=\"off\" button_one_text_color__hover_enabled=\"off\" button_two_text_color__hover_enabled=\"off\" button_border_width__hover_enabled=\"off\" button_one_border_width__hover_enabled=\"off\" button_two_border_width__hover_enabled=\"off\" button_border_color__hover_enabled=\"off\" button_one_border_color__hover_enabled=\"off\" button_two_border_color__hover_enabled=\"off\" button_border_radius__hover_enabled=\"off\" button_one_border_radius__hover_enabled=\"off\" button_two_border_radius__hover_enabled=\"off\" button_letter_spacing__hover_enabled=\"on\" button_letter_spacing__hover=\"1px\" button_one_letter_spacing__hover_enabled=\"off\" button_two_letter_spacing__hover_enabled=\"off\" button_bg_color__hover_enabled=\"off\" button_one_bg_color__hover_enabled=\"off\" button_two_bg_color__hover_enabled=\"off\"]<\/p><p>Wir unterst\u00fctzen Sie bei der Einrichtung eines Vigilanz-Systems, den Meldepflichten bei unerw\u00fcnschten Ereignissen, der Post-Market Surveillance, Post-Market Clinical Follow-up-Studien etc.<\/p><p>[\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\"1_2,1_2\" _builder_version=\"4.11.1\" custom_margin=\"||||false|false\" global_colors_info=\"{}\"][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_cta title=\"Pharmazeutische Entwicklung\" button_url=\"\/medizinprodukte-pharmazeutische-entwicklung\" button_text=\"Weitere Infos\" _builder_version=\"4.14.2\" header_font=\"Manrope|600|||||||\" header_text_color=\"#FFFFFF\" header_line_height=\"1.2em\" body_font=\"Manrope||||||||\" body_text_color=\"#FFFFFF\" body_line_height=\"2em\" background_color=\"#16918f\" use_background_color_gradient=\"on\" background_color_gradient_start=\"#16918f\" background_color_gradient_end=\"#1bb5b2\" background_color_gradient_direction=\"150deg\" background_image=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png\" background_position=\"bottom_left\" custom_button=\"on\" button_text_size=\"13px\" button_text_color=\"#ffffff\" button_bg_color=\"RGBA(0,0,0,0)\" button_border_width=\"2px\" button_border_color=\"#FFFFFF\" button_border_radius=\"0px\" button_letter_spacing=\"1px\" button_font=\"Manrope|||on|||||\" button_icon=\"$||divi||400\" button_icon_color=\"#FFFFFF\" text_orientation=\"left\" custom_margin=\"|||\" custom_padding=\"|||\" custom_padding_phone=\"|0px||\" custom_padding_last_edited=\"off|desktop\" animation_style=\"zoom\" animation_delay=\"200ms\" animation_intensity_zoom=\"20%\" box_shadow_style=\"preset1\" box_shadow_vertical=\"90px\" box_shadow_blur=\"160px\" box_shadow_color=\"rgba(0,0,0,0.06)\" box_shadow_style_button=\"preset1\" box_shadow_vertical_button=\"20px\" box_shadow_blur_button=\"30px\" box_shadow_color_button=\"rgba(0,0,0,0.1)\" button_letter_spacing_hover=\"1px\" locked=\"off\" global_colors_info=\"{}\" button_text_size__hover_enabled=\"off\" button_one_text_size__hover_enabled=\"off\" button_two_text_size__hover_enabled=\"off\" button_text_color__hover_enabled=\"off\" button_one_text_color__hover_enabled=\"off\" button_two_text_color__hover_enabled=\"off\" button_border_width__hover_enabled=\"off\" button_one_border_width__hover_enabled=\"off\" button_two_border_width__hover_enabled=\"off\" button_border_color__hover_enabled=\"off\" button_one_border_color__hover_enabled=\"off\" button_two_border_color__hover_enabled=\"off\" button_border_radius__hover_enabled=\"off\" button_one_border_radius__hover_enabled=\"off\" button_two_border_radius__hover_enabled=\"off\" button_letter_spacing__hover_enabled=\"on\" button_letter_spacing__hover=\"1px\" button_one_letter_spacing__hover_enabled=\"off\" button_two_letter_spacing__hover_enabled=\"off\" button_bg_color__hover_enabled=\"off\" button_one_bg_color__hover_enabled=\"off\" button_two_bg_color__hover_enabled=\"off\"]<\/p><p>Wir begleiten Sie von der Produktidee \u00fcber die galenische Entwicklung\/Rezeptur bis zur Lohnherstellung Ihres Medizinproduktes.<\/p><p>[\/et_pb_cta][\/et_pb_column][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_cta title=\"In- & Outlicensing\" button_url=\"\/medizinprodukte-in-und-outlicensing\" button_text=\"Weitere Infos\" _builder_version=\"4.14.2\" header_font=\"Manrope|600|||||||\" header_text_color=\"#FFFFFF\" header_line_height=\"1.2em\" body_font=\"Manrope||||||||\" body_text_color=\"#FFFFFF\" body_line_height=\"2em\" background_color=\"#16918f\" use_background_color_gradient=\"on\" background_color_gradient_start=\"#16918f\" background_color_gradient_end=\"#1bb5b2\" background_color_gradient_direction=\"150deg\" background_image=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png\" background_position=\"bottom_left\" custom_button=\"on\" button_text_size=\"13px\" button_text_color=\"#ffffff\" button_bg_color=\"RGBA(0,0,0,0)\" button_border_width=\"2px\" button_border_color=\"#FFFFFF\" button_border_radius=\"0px\" button_letter_spacing=\"1px\" button_font=\"Manrope|||on|||||\" button_icon=\"$||divi||400\" button_icon_color=\"#FFFFFF\" text_orientation=\"left\" custom_margin=\"|||\" custom_padding=\"|||\" custom_padding_phone=\"|0px||\" custom_padding_last_edited=\"off|desktop\" animation_style=\"zoom\" animation_delay=\"200ms\" animation_intensity_zoom=\"20%\" hover_enabled=\"0\" box_shadow_style=\"preset1\" box_shadow_vertical=\"90px\" box_shadow_blur=\"160px\" box_shadow_color=\"rgba(0,0,0,0.06)\" box_shadow_style_button=\"preset1\" box_shadow_vertical_button=\"20px\" box_shadow_blur_button=\"30px\" box_shadow_color_button=\"rgba(0,0,0,0.1)\" button_letter_spacing_hover=\"1px\" locked=\"off\" global_colors_info=\"{}\" button_text_size__hover_enabled=\"off\" button_one_text_size__hover_enabled=\"off\" button_two_text_size__hover_enabled=\"off\" button_text_color__hover_enabled=\"off\" button_one_text_color__hover_enabled=\"off\" button_two_text_color__hover_enabled=\"off\" button_border_width__hover_enabled=\"off\" button_one_border_width__hover_enabled=\"off\" button_two_border_width__hover_enabled=\"off\" button_border_color__hover_enabled=\"off\" button_one_border_color__hover_enabled=\"off\" button_two_border_color__hover_enabled=\"off\" button_border_radius__hover_enabled=\"off\" button_one_border_radius__hover_enabled=\"off\" button_two_border_radius__hover_enabled=\"off\" button_letter_spacing__hover_enabled=\"on\" button_letter_spacing__hover=\"1px\" button_one_letter_spacing__hover_enabled=\"off\" button_two_letter_spacing__hover_enabled=\"off\" button_bg_color__hover_enabled=\"off\" button_one_bg_color__hover_enabled=\"off\" button_two_bg_color__hover_enabled=\"off\" sticky_enabled=\"0\"]<\/p><p>Umsatzsteigerung durch nationale und internationale Vermarktung von Lizenz- und Vertriebsrechten sowie Akquisitionen von Medizinprodukten.<\/p><p>[\/et_pb_cta][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\"1_2,1_2\" _builder_version=\"4.11.1\" custom_margin=\"||60px||false|false\" global_colors_info=\"{}\"][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_cta title=\"Import & Export \" button_url=\"\/medizinprodukte-import-export\" button_text=\"Weitere Infos\" _builder_version=\"4.14.2\" header_font=\"Manrope|600|||||||\" header_text_color=\"#FFFFFF\" header_line_height=\"1.2em\" body_font=\"Manrope||||||||\" body_text_color=\"#FFFFFF\" body_line_height=\"2em\" background_color=\"#16918f\" use_background_color_gradient=\"on\" background_color_gradient_start=\"#16918f\" background_color_gradient_end=\"#1bb5b2\" background_color_gradient_direction=\"150deg\" background_image=\"https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/09\/kontur.png\" background_position=\"bottom_left\" custom_button=\"on\" button_text_size=\"13px\" button_text_color=\"#ffffff\" button_bg_color=\"RGBA(0,0,0,0)\" button_border_width=\"2px\" button_border_color=\"#FFFFFF\" button_border_radius=\"0px\" button_letter_spacing=\"1px\" button_font=\"Manrope|||on|||||\" button_icon=\"$||divi||400\" button_icon_color=\"#FFFFFF\" text_orientation=\"left\" custom_margin=\"|||\" custom_padding=\"|||\" custom_padding_phone=\"|0px||\" custom_padding_last_edited=\"off|desktop\" animation_style=\"zoom\" animation_delay=\"200ms\" animation_intensity_zoom=\"20%\" box_shadow_style=\"preset1\" box_shadow_vertical=\"90px\" box_shadow_blur=\"160px\" box_shadow_color=\"rgba(0,0,0,0.06)\" box_shadow_style_button=\"preset1\" box_shadow_vertical_button=\"20px\" box_shadow_blur_button=\"30px\" box_shadow_color_button=\"rgba(0,0,0,0.1)\" button_letter_spacing_hover=\"1px\" locked=\"off\" global_colors_info=\"{}\" button_text_size__hover_enabled=\"off\" button_one_text_size__hover_enabled=\"off\" button_two_text_size__hover_enabled=\"off\" button_text_color__hover_enabled=\"off\" button_one_text_color__hover_enabled=\"off\" button_two_text_color__hover_enabled=\"off\" button_border_width__hover_enabled=\"off\" button_one_border_width__hover_enabled=\"off\" button_two_border_width__hover_enabled=\"off\" button_border_color__hover_enabled=\"off\" button_one_border_color__hover_enabled=\"off\" button_two_border_color__hover_enabled=\"off\" button_border_radius__hover_enabled=\"off\" button_one_border_radius__hover_enabled=\"off\" button_two_border_radius__hover_enabled=\"off\" button_letter_spacing__hover_enabled=\"on\" button_letter_spacing__hover=\"1px\" button_one_letter_spacing__hover_enabled=\"off\" button_two_letter_spacing__hover_enabled=\"off\" button_bg_color__hover_enabled=\"off\" button_one_bg_color__hover_enabled=\"off\" button_two_bg_color__hover_enabled=\"off\"]<\/p><p>Schnelle und unkomplizierte Umsetzung der regulatorischen und zollrechtlichen Bestimmungen bei der Einfuhr und Ausfuhr von Medizinprodukten.<\/p><p>[\/et_pb_cta][\/et_pb_column][et_pb_column type=\"1_2\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"class_list":["post-3422","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical devices \u00bbISO13485, EU-MDR, FDA 510(k), 21CFRpart 820<\/title>\n<meta name=\"description\" content=\"Our medical device services: FDA \u2714 510(k) \u2714 21 CFR part 820 \u2714 Conformity assessment \u2714 EU-MDR\u2714 CE marking \u2714 Notified body \u2714 T\u00dcV \u2714 QMS \u27a8 contact.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-expertise.com\/en\/medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical devices \u00bbISO13485, EU-MDR, FDA 510(k), 21CFRpart 820\" \/>\n<meta property=\"og:description\" content=\"Our medical device services: FDA \u2714 510(k) \u2714 21 CFR part 820 \u2714 Conformity assessment \u2714 EU-MDR\u2714 CE marking \u2714 Notified body \u2714 T\u00dcV \u2714 QMS \u27a8 contact.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharma-expertise.com\/en\/medical-devices\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Expertise Consulting\" \/>\n<meta property=\"article:modified_time\" content=\"2022-10-27T09:37:48+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/medical-devices\\\/\",\"url\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/medical-devices\\\/\",\"name\":\"Medical devices \u00bbISO13485, EU-MDR, FDA 510(k), 21CFRpart 820\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/#website\"},\"datePublished\":\"2022-02-24T13:58:28+00:00\",\"dateModified\":\"2022-10-27T09:37:48+00:00\",\"description\":\"Our medical device services: FDA \u2714 510(k) \u2714 21 CFR part 820 \u2714 Conformity assessment \u2714 EU-MDR\u2714 CE marking \u2714 Notified body \u2714 T\u00dcV \u2714 QMS \u27a8 contact.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/medical-devices\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/medical-devices\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/medical-devices\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Medical Devices\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/#website\",\"url\":\"https:\\\/\\\/pharma-expertise.com\\\/\",\"name\":\"Pharma Expertise Consulting\",\"description\":\"Your expert in pharma solutions\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/pharma-expertise.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Medical devices \u00bbISO13485, EU-MDR, FDA 510(k), 21CFRpart 820","description":"Our medical device services: FDA \u2714 510(k) \u2714 21 CFR part 820 \u2714 Conformity assessment \u2714 EU-MDR\u2714 CE marking \u2714 Notified body \u2714 T\u00dcV \u2714 QMS \u27a8 contact.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/pharma-expertise.com\/en\/medical-devices\/","og_locale":"en_US","og_type":"article","og_title":"Medical devices \u00bbISO13485, EU-MDR, FDA 510(k), 21CFRpart 820","og_description":"Our medical device services: FDA \u2714 510(k) \u2714 21 CFR part 820 \u2714 Conformity assessment \u2714 EU-MDR\u2714 CE marking \u2714 Notified body \u2714 T\u00dcV \u2714 QMS \u27a8 contact.","og_url":"https:\/\/pharma-expertise.com\/en\/medical-devices\/","og_site_name":"Pharma Expertise Consulting","article_modified_time":"2022-10-27T09:37:48+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/pharma-expertise.com\/en\/medical-devices\/","url":"https:\/\/pharma-expertise.com\/en\/medical-devices\/","name":"Medical devices \u00bbISO13485, EU-MDR, FDA 510(k), 21CFRpart 820","isPartOf":{"@id":"https:\/\/pharma-expertise.com\/#website"},"datePublished":"2022-02-24T13:58:28+00:00","dateModified":"2022-10-27T09:37:48+00:00","description":"Our medical device services: FDA \u2714 510(k) \u2714 21 CFR part 820 \u2714 Conformity assessment \u2714 EU-MDR\u2714 CE marking \u2714 Notified body \u2714 T\u00dcV \u2714 QMS \u27a8 contact.","breadcrumb":{"@id":"https:\/\/pharma-expertise.com\/en\/medical-devices\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/pharma-expertise.com\/en\/medical-devices\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/pharma-expertise.com\/en\/medical-devices\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/pharma-expertise.com\/en\/"},{"@type":"ListItem","position":2,"name":"Medical Devices"}]},{"@type":"WebSite","@id":"https:\/\/pharma-expertise.com\/#website","url":"https:\/\/pharma-expertise.com\/","name":"Pharma Expertise Consulting","description":"Your expert in pharma solutions","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/pharma-expertise.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/pharma-expertise.com\/en\/wp-json\/wp\/v2\/pages\/3422","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharma-expertise.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pharma-expertise.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pharma-expertise.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharma-expertise.com\/en\/wp-json\/wp\/v2\/comments?post=3422"}],"version-history":[{"count":19,"href":"https:\/\/pharma-expertise.com\/en\/wp-json\/wp\/v2\/pages\/3422\/revisions"}],"predecessor-version":[{"id":3918,"href":"https:\/\/pharma-expertise.com\/en\/wp-json\/wp\/v2\/pages\/3422\/revisions\/3918"}],"wp:attachment":[{"href":"https:\/\/pharma-expertise.com\/en\/wp-json\/wp\/v2\/media?parent=3422"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}