[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”4.16″ _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=”4.18.1″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ custom_margin=”||0px||false|false” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.18.1″ text_font=”||||||||” 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=”1.2em” header_3_font=”Manrope|500|||||||” header_3_font_size=”20px” header_3_line_height=”1.4em” custom_margin=”0px||0px||false|false” hover_enabled=”0″ 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=”{}” sticky_enabled=”0″]<\/p>\n
[\/et_pb_text][et_pb_text _builder_version=”4.18.1″ _module_preset=”default” text_font=”Manrope||||||||” text_text_color=”#6d7c90″ header_font=”Manrope|600|||||||” custom_margin=”0px||||false|false” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
Depending on the country where the medical device is to be marketed in, companies have to fulfill different regulations such as the European Medical Device Regulation (EUMDR)<\/a><\/strong> for European countries or for the US market FDA Code of Federal Regulations (CFR) 21<\/strong><\/a>.<\/p>\n For the European market, the creation and maintenance of technical documentation<\/strong> must comply with the requirements of the European Medical Device Regulation (EUMDR) <\/strong><\/a>and other CE directives. For the US market, manufacturers have to adhere to the Code of Federal Regulations (CFR) 21<\/strong><\/a> for the different FDA<\/a><\/strong> submission pathways such as \u00a0510(k) (21 CFR 807)\u00a0<\/strong><\/a>,\u00a0PMA (21 CFR. 814.42)<\/a> <\/strong>or De Novo 513(f)(2)<\/a><\/strong>. <\/strong>Companies are also advised to participate in a Medical Device Single Audit Program (MDSAP)<\/strong><\/a>. The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.<\/p>\n Successful approval<\/strong> of a medical device from the FDA or an European Notified Body <\/strong>includes risk analysis<\/strong>, risk assessment, and<\/strong>\u00a0clinical evaluation <\/strong>to demonstrate performance<\/strong> and efficacy. Moreover, each company needs<\/strong> a comprehensive<\/strong> Quality Management System (QMS)<\/strong><\/a> based on ISO 13485 and the Code of Federal Regulations (CFR) Title 21, Subchapter H, Part 820, Quality System Regulation<\/strong><\/a>.<\/p>\n Likewise, it is important to establish an efficient regulatory strategy<\/strong>. This includes the determination of the FDA classification of the medical device<\/strong><\/a>, identification of regulatory opportunities and limitations and their connection to the proposed intended use, the classification of the product based on the selected regulatory systems, the consideration of applicable laws and standards, the listing of additional regulatory requirements such as a QMS, the determination of the registration sequence for different countries, and, overall, the review of the regulatory pathway (510 (k), PMA, DeNovo in consultation with the Notified Body or the FDA.<\/p>\n Pharma Expertise Consulting supports you throughout the FDA submission process<\/strong><\/a>\/ the EU CE Marking process<\/strong><\/a> \u00a0from the selection of a qualified and reliable Notified Body to the entire approval process with a National Competent Authority (NCA) or the FDA.<\/strong><\/p>\n Once an approval concept is established, we assist you in setting up a documentation architecture, listing and prototyping the required documents, updating the risk management file, organizing the design control and V&V support documentation, organizing process controls (including supplier audits), conducting clinical trials<\/strong><\/a> and preparing clinical evaluation reports<\/strong>, and implementing<\/strong> a QMS<\/strong> <\/a>compliant with Quality System Regulation QSR<\/strong><\/a> persuant with ISO 13485:2016<\/strong><\/a> and the CFR 21, Subchapter H, Part 820, Quality Sytsem Regulation.<\/strong><\/a><\/p>\n Pharma Expertise Consulting ensures monitoring, compliance, and maintenance of medical devices<\/strong> and in vitro diagnostics throughout the entire product life cycle.<\/p>\n Do you need support in medical device regulatory affairs? Feel free to contact us!<\/strong><\/p>\n [\/et_pb_text][et_pb_button button_url=”\/en\/contact” button_text=”Make a consultation appointment” _builder_version=”4.16″ _module_preset=”default” custom_button=”on” button_text_size=”13px” button_text_color=”#FFFFFF” button_bg_color=”#16918f” button_border_width=”4px” button_border_color=”#16918f” button_border_radius=”0px” button_font=”Manrope|||on|||||” button_icon=”$||divi||400″ button_icon_color=”#FFFFFF” background_layout=”dark” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Service Section” _builder_version=”4.16″ background_color=”#f7f7f7″ custom_margin=”0px||0px||false|false” custom_padding=”70px||70px||false|false” global_colors_info=”{}”][et_pb_row admin_label=”Service Section Title” _builder_version=”4.16″ custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” animation_style=”fade” animation_direction=”top” saved_tabs=”all” 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global_colors_info=”{}”][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.16″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n Supplier qualification<\/strong> and evaluation<\/strong><\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.16″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n Audits, self-inspections<\/strong><\/p>\n \u00a0<\/strong><\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.16″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n Training of employees<\/strong><\/p>\n \u00a0<\/strong><\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.16″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n Market surveillance<\/strong> [\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,1_4,1_4,1_4″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” admin_label=”Services” _builder_version=”4.16″ max_width=”80%” custom_margin=”0px||0px||false|false” custom_padding=”0px||40px||false|false” use_custom_width=”on” width_unit=”off” global_colors_info=”{}”][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.16″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n Literature research<\/strong><\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.16″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n Adjustments <\/strong>of risk assessments<\/strong> and [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_blurb use_icon=”on” font_icon=”R||divi||400″ icon_color=”#16918f” image_icon_width=”60px” _builder_version=”4.16″ header_font=”Montserrat|on|||” header_text_color=”#353740″ header_font_size=”22px” header_line_height=”1.4em” body_font=”Manrope||||||||” body_text_color=”#6d7c90″ text_orientation=”center” custom_padding=”30px|30px|30px|30px” animation_style=”zoom” border_width_all=”0px” border_color_all=”#dddddd” border_style_all=”solid” use_border_color=”on” border_color=”#dddddd” icon_font_size=”60px” global_colors_info=”{}”]<\/p>\n Post-market clinical follow-up (PMCF)<\/strong><\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" Regulatory Affairs (approval) From regulatory strategy to successful market approval and maintenance of your medical devicesDepending on the country where the medical device is to be marketed in, companies have to fulfill different regulations such as the European Medical Device Regulation (EUMDR) for European countries or for the US market FDA Code of Federal Regulations […]<\/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":" [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\" _builder_version=\"4.10.7\" 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header_3_font_size_phone=\"20px\" header_3_font_size_last_edited=\"on|phone\" locked=\"off\" global_colors_info=\"{}\"]<\/p> [\/et_pb_text][et_pb_text _builder_version=\"4.14.2\" _module_preset=\"default\" text_font=\"Manrope||||||||\" text_text_color=\"#6d7c90\" header_font=\"Manrope|600|||||||\" custom_margin=\"0px||||false|false\" hover_enabled=\"0\" global_colors_info=\"{}\" sticky_enabled=\"0\"]<\/p> Die in Deutschland zugelassenen Medizinprodukte unterliegen einer Vielzahl von Verordnungen und Gesetzen, wie dem Medizinproduktegesetz (MPG), der Medizinproduktebetreiberverordnung (MPBetreibV), den europ\u00e4ischen Richtlinien \u00fcber aktive Implantate (90\/385\/EWG), Medizinprodukte (93\/42\/EWG) und In-vitro\u2010Diagnostika (98\/79\/EG) und den Medical Devices Documents (MEDDEV), sowie deren Umsetzung in nationales Recht.<\/p> Die Erstellung und Pflege der technischen Dokumentation<\/strong> muss den Anforderungen der Medical Device Regulation (MDR), weiteren CE-Richtlinien sowie deren Anwendung bei internationalen Zulassungen (Vorgaben der US Food and Drug Administration (FDA<\/a>)) und dem Medical Device Single Audit Program (MDSAP)\u00a0entsprechen.<\/p> Die erfolgreiche Zulassung eines Medizinproduktes beinhaltet die Risikoanalyse<\/strong> und die Risikobewertung zum Nachweis der Sicherheit<\/strong>, die Durchf\u00fchrung einer klinischen Bewertung<\/a>, die Pr\u00fcfung zum Nachweis der Leistungsf\u00e4higkeit und Wirksamkeit<\/strong> sowie ein umfassendes Qualit\u00e4tsmanagementsystem (QMS)<\/a><\/strong>.<\/p> Ebenfalls gilt es, eine effiziente Zulassungsstrategie<\/strong> festzulegen. Sie beinhaltet die Identifizierung der regulatorischen M\u00f6glichkeiten und Grenzen sowie deren Verbindung mit dem vorgeschlagenen Verwendungszweck, die Einstufung des Produkts auf der Grundlage der ausgew\u00e4hlten Regulierungssysteme, die Ber\u00fccksichtigung geltender Gesetze und Normen, die Auflistung zus\u00e4tzlicher regulatorischer Auflagen wie ein QMS, die Festlegung der Registrierungsreihenfolge f\u00fcr verschiedene L\u00e4nder sowie insgesamt die \u00dcberpr\u00fcfung des regulatorischen Weges in Absprache mit der Benannten Stelle.<\/p> Pharma Expertise Consulting unterst\u00fctzt Sie im gesamten CE-Kennzeichnungsprozess<\/strong><\/a>, von der Auswahl einer qualifizierten und zuverl\u00e4ssigen Benannten Stelle<\/strong>\u00a0bis hin zum gesamten Zulassungsprozess<\/strong>\u00a0bei einer National Competent Authority (NCA)<\/strong>.<\/p> Sobald ein Zulassungskonzept feststeht, unterst\u00fctzen wir Sie beim Aufbau einer Dokumentationsarchitektur, der Auflistung und dem Prototyping der erforderlichen Dokumente<\/strong>, der\u00a0Aktualisierung der Risikomanagementdatei<\/strong>, der\u00a0Organisation der Designkontroll- und V&V-Unterst\u00fctzungsdokumentation<\/strong>, der\u00a0Organisation der Prozesskontrollen<\/strong>, einschlie\u00dflich Lieferantenaudits, der Durchf\u00fchrung der klinischen Pr\u00fcfungen<\/a><\/strong> und Erstellung der klinischen Bewertungsberichte sowie der <\/strong>Einf\u00fchrung eines QMS<\/strong><\/a>, das mit QSR (Verfahren der Qualit\u00e4tssicherung nach Routinedaten)<\/strong>\u00a0und\/oder ISO 13485:2016<\/strong> konform ist.<\/p> Pharma Expertise Consulting sichert die \u00dcberwachung und Aufrechterhaltung der Konformit\u00e4t von Medizinprodukten<\/strong> und In-vitro-Diagnostika <\/strong>\u00fcber den gesamten Produktlebenszyklus.<\/p> Sie ben\u00f6tigen Unterst\u00fctzung in der Medizinprodukte-Zulassung? Sprechen Sie uns gerne an!<\/strong><\/p> [\/et_pb_text][et_pb_button button_url=\"\/kontakt\" button_text=\"Beratungstermin vereinbaren\" _builder_version=\"4.13.0\" _module_preset=\"default\" custom_button=\"on\" button_text_size=\"13px\" button_text_color=\"#FFFFFF\" button_bg_color=\"#16918f\" button_border_width=\"4px\" button_border_color=\"#16918f\" button_border_radius=\"0px\" button_font=\"Manrope|||on|||||\" button_icon=\"$||divi||400\" button_icon_color=\"#FFFFFF\" background_layout=\"dark\" global_colors_info=\"{}\"][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\"1\" admin_label=\"Service Section\" _builder_version=\"4.13.0\" background_color=\"#f7f7f7\" custom_margin=\"0px||0px||false|false\" custom_padding=\"70px||70px||false|false\" global_colors_info=\"{}\"][et_pb_row admin_label=\"Service Section Title\" _builder_version=\"4.13.0\" custom_margin=\"0px||0px||false|false\" custom_padding=\"0px||0px||false|false\" 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max_width=\"80%\" custom_margin=\"0px||0px||false|false\" custom_padding=\"0px||0px||false|false\" use_custom_width=\"on\" width_unit=\"off\" global_colors_info=\"{}\"][et_pb_column type=\"1_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_blurb use_icon=\"on\" font_icon=\"R||divi||400\" icon_color=\"#16918f\" image_icon_width=\"60px\" _builder_version=\"4.14.2\" header_font=\"Montserrat|on|||\" header_text_color=\"#353740\" header_font_size=\"22px\" header_line_height=\"1.4em\" body_font=\"Manrope||||||||\" body_text_color=\"#6d7c90\" text_orientation=\"center\" custom_padding=\"30px|30px|30px|30px\" animation_style=\"zoom\" border_width_all=\"0px\" border_color_all=\"#dddddd\" border_style_all=\"solid\" use_border_color=\"on\" border_color=\"#dddddd\" icon_font_size=\"60px\" global_colors_info=\"{}\"]<\/p> Lieferantenqualifizierung<\/strong> und -bewertung<\/strong><\/p> [\/et_pb_blurb][\/et_pb_column][et_pb_column type=\"1_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_blurb use_icon=\"on\" font_icon=\"R||divi||400\" icon_color=\"#16918f\" image_icon_width=\"60px\" _builder_version=\"4.13.0\" header_font=\"Montserrat|on|||\" header_text_color=\"#353740\" header_font_size=\"22px\" header_line_height=\"1.4em\" body_font=\"Manrope||||||||\" body_text_color=\"#6d7c90\" text_orientation=\"center\" custom_padding=\"30px|30px|30px|30px\" animation_style=\"zoom\" border_width_all=\"0px\" border_color_all=\"#dddddd\" border_style_all=\"solid\" use_border_color=\"on\" border_color=\"#dddddd\" icon_font_size=\"60px\" global_colors_info=\"{}\"]<\/p> Audits<\/strong>, Selbstinspektionen<\/strong><\/p> [\/et_pb_blurb][\/et_pb_column][et_pb_column type=\"1_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_blurb use_icon=\"on\" font_icon=\"R||divi||400\" icon_color=\"#16918f\" image_icon_width=\"60px\" _builder_version=\"4.13.0\" header_font=\"Montserrat|on|||\" header_text_color=\"#353740\" header_font_size=\"22px\" header_line_height=\"1.4em\" body_font=\"Manrope||||||||\" body_text_color=\"#6d7c90\" text_orientation=\"center\" custom_padding=\"30px|30px|30px|30px\" animation_style=\"zoom\" border_width_all=\"0px\" border_color_all=\"#dddddd\" border_style_all=\"solid\" use_border_color=\"on\" border_color=\"#dddddd\" icon_font_size=\"60px\" global_colors_info=\"{}\"]<\/p> Schulungen der Mitarbeiter<\/strong><\/p> [\/et_pb_blurb][\/et_pb_column][et_pb_column type=\"1_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_blurb use_icon=\"on\" font_icon=\"R||divi||400\" icon_color=\"#16918f\" image_icon_width=\"60px\" _builder_version=\"4.14.2\" header_font=\"Montserrat|on|||\" header_text_color=\"#353740\" header_font_size=\"22px\" header_line_height=\"1.4em\" body_font=\"Manrope||||||||\" body_text_color=\"#6d7c90\" text_orientation=\"center\" custom_padding=\"30px|30px|30px|30px\" animation_style=\"zoom\" border_width_all=\"0px\" border_color_all=\"#dddddd\" border_style_all=\"solid\" use_border_color=\"on\" border_color=\"#dddddd\" icon_font_size=\"60px\" global_colors_info=\"{}\"]<\/p> Markt\u00fcberwachung<\/strong> [\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\"1_4,1_4,1_4,1_4\" use_custom_gutter=\"on\" gutter_width=\"2\" make_equal=\"on\" admin_label=\"Services\" _builder_version=\"4.13.0\" max_width=\"80%\" custom_margin=\"0px||0px||false|false\" custom_padding=\"0px||40px||false|false\" use_custom_width=\"on\" width_unit=\"off\" global_colors_info=\"{}\"][et_pb_column type=\"1_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_blurb use_icon=\"on\" font_icon=\"R||divi||400\" icon_color=\"#16918f\" image_icon_width=\"60px\" _builder_version=\"4.14.2\" header_font=\"Montserrat|on|||\" header_text_color=\"#353740\" header_font_size=\"22px\" header_line_height=\"1.4em\" body_font=\"Manrope||||||||\" body_text_color=\"#6d7c90\" text_orientation=\"center\" custom_padding=\"30px|30px|30px|30px\" animation_style=\"zoom\" border_width_all=\"0px\" border_color_all=\"#dddddd\" border_style_all=\"solid\" use_border_color=\"on\" border_color=\"#dddddd\" icon_font_size=\"60px\" global_colors_info=\"{}\"]<\/p> Literaturrecherchen<\/strong><\/p> [\/et_pb_blurb][\/et_pb_column][et_pb_column type=\"1_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_blurb use_icon=\"on\" font_icon=\"R||divi||400\" icon_color=\"#16918f\" image_icon_width=\"60px\" _builder_version=\"4.14.2\" header_font=\"Montserrat|on|||\" header_text_color=\"#353740\" header_font_size=\"22px\" header_line_height=\"1.4em\" body_font=\"Manrope||||||||\" body_text_color=\"#6d7c90\" text_orientation=\"center\" custom_padding=\"30px|30px|30px|30px\" animation_style=\"zoom\" border_width_all=\"0px\" border_color_all=\"#dddddd\" border_style_all=\"solid\" use_border_color=\"on\" border_color=\"#dddddd\" icon_font_size=\"60px\" global_colors_info=\"{}\"]<\/p> Anpassungen<\/strong> von Risikobewertungen<\/strong> und [\/et_pb_blurb][\/et_pb_column][et_pb_column type=\"1_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_blurb use_icon=\"on\" font_icon=\"R||divi||400\" icon_color=\"#16918f\" image_icon_width=\"60px\" _builder_version=\"4.14.2\" header_font=\"Montserrat|on|||\" header_text_color=\"#353740\" header_font_size=\"22px\" header_line_height=\"1.4em\" body_font=\"Manrope||||||||\" body_text_color=\"#6d7c90\" text_orientation=\"center\" custom_padding=\"30px|30px|30px|30px\" animation_style=\"zoom\" border_width_all=\"0px\" border_color_all=\"#dddddd\" border_style_all=\"solid\" use_border_color=\"on\" border_color=\"#dddddd\" icon_font_size=\"60px\" global_colors_info=\"{}\"]<\/p> Post-Market Clinical Follow-up<\/strong> (PMCF<\/strong>)<\/p> [\/et_pb_blurb][\/et_pb_column][et_pb_column type=\"1_4\" _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-3496","page","type-page","status-publish","hentry"],"yoast_head":"\nOur medical device maintenance services:<\/h2>\n
(Post-Market Surveillance)<\/strong><\/p>\n
clinical evaluations
<\/strong><\/p>\nRegulatory Affairs (Zulassung)<\/h2>
Von der Zulassungsstrategie bis zur erfolgreichen Marktzulassung und Maintenance Ihrer Medizinprodukte<\/h1>
Unsere Medizinprodukte-Maintenance-Services:<\/h2>
(Post-Market Surveillance<\/strong>)<\/p>
klinischen Bewertungen<\/strong><\/p>