{"id":3488,"date":"2022-03-02T12:03:52","date_gmt":"2022-03-02T12:03:52","guid":{"rendered":"https:\/\/pharma-expertise.com\/?page_id=3488"},"modified":"2022-11-04T17:38:32","modified_gmt":"2022-11-04T17:38:32","slug":"quality-management-system","status":"publish","type":"page","link":"https:\/\/pharma-expertise.com\/en\/quality-management-system\/","title":{"rendered":"Quality Management System"},"content":{"rendered":"

[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=”4.16″ _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” custom_margin=”||||false|false” custom_padding=”||||false|false” 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=”Rubik|500|||||||” header_3_font_size=”38px” 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

Quality Management System (QMS)<\/h2>\n

The quality management system (QMS) as a duty for every medical device manufacturer<\/h1>\n

[\/et_pb_text][et_pb_text _builder_version=”4.18.1″ text_font=”Manrope||||||||” text_text_color=”#6d7c90″ header_font=”Manrope|600|||||||” header_line_height=”1.4em” header_2_font=”Rubik|500||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||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

Manufacturers of medical devices<\/strong> must have a quality management system (QMS)<\/strong>. The establishment and maintenance of QMS were originally based on the DIN EN ISO 9001<\/strong> standard. Since 2003, the harmonized DIN EN ISO 13485:2012<\/strong> standard commissioned by the EU Commission has been in force. In Europe, the QMS of medical device manufacturers are certified by state Notified Bodies. For the US market, the quality management system (QMS)<\/strong> has to conform to the FDA<\/strong><\/a> regulations (Quality System Regulation 21 CFR 820)<\/strong><\/a> as well as to the ISO 13485: 2016<\/strong>.<\/p>\n

After initial certification<\/strong>, annual repeat audits by the Notified Bodies\/take place, followed by certification audits every five years at the latest. If successful, the notified body issues a certificate of conformity<\/strong>. Only this certificate entitles the manufacturer to issue the declaration of conformity<\/strong> <\/a>and to affix the CE marking<\/strong> <\/a>to his product.<\/p>\n

With the establishment of the QMS, we also integrate Good<\/strong> Manufacturing Practice (GMP)<\/strong><\/a> requirements. Likewise, the system should be quickly integrated into the daily routine so it can support the management of the company. Pharma Expertise Consulting offers an audit service to ensure that medical devices meet the specified quality requirements. We also undertake qualification and auditing of suppliers and contract manufacturers, self-inspections of medical device manufacturers, and simulate unannounced audits of Notified Bodies in order to check and continually improve existing processes.<\/p>\n

We help you comply with the relevant quality requirements to market your medical devices.<\/strong> Feel free to contact us!<\/strong><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][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” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text admin_label=”Title” _builder_version=”4.16″ text_font=”Montserrat||||||||” text_text_color=”#747d88″ text_line_height=”1.9em” header_font=”||||||||” header_2_font=”Manrope|600|||||||” header_2_text_color=”#20292f” header_2_line_height=”1.4em” text_orientation=”center” max_width=”700px” module_alignment=”center” animation_style=”slide” animation_direction=”bottom” animation_intensity_slide=”4%” global_colors_info=”{}”]<\/p>\n

Our services in quality management for medical devices:<\/h2>\n

[\/et_pb_text][\/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||0px||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=”4.17.3″ 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

Establishment of a QMS
including certification
(e.g., ISO 13485 certification)<\/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

Integration of multiple requirements (guidelines, MDR, IVDR, ISO 13485, USA QSR, Japan Ord. 169, Brazil RDC 16\/2013)<\/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

Compilation<\/strong> of documentation (company-specific structure<\/strong> and processes)<\/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

Flexible QMS documentation for quick adaptation<\/p>\n

[\/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

Training<\/strong> and support<\/strong> during the entire certification<\/strong> and approval process<\/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

Performance<\/strong> of audits<\/strong> and 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

Accompaniment<\/strong> of audits<\/strong>
by the notified body<\/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_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

Quality Management System (QMS) The quality management system (QMS) as a duty for every medical device manufacturerManufacturers of medical devices must have a quality management system (QMS). The establishment and maintenance of QMS were originally based on the DIN EN ISO 9001 standard. Since 2003, the harmonized DIN EN ISO 13485:2012 standard commissioned by the […]<\/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=\"4.11.1\" _module_preset=\"default\" custom_margin=\"||||false|false\" custom_padding=\"||||false|false\" 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=\"||||||||\" 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=\"Rubik|500|||||||\" header_3_font_size=\"38px\" header_3_line_height=\"1.4em\" custom_margin=\"0px||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>

Qualit\u00e4tsmanagementsystem\u200b (QMS)<\/h2>

Das Qualit\u00e4tsmanagementsystem (QMS) als Pflicht f\u00fcr jeden Medizinprodukte-Hersteller<\/h1>

[\/et_pb_text][et_pb_text _builder_version=\"4.14.2\" text_font=\"Manrope||||||||\" text_text_color=\"#6d7c90\" header_font=\"Manrope|600|||||||\" header_line_height=\"1.4em\" header_2_font=\"Rubik|500||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||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>

Hersteller von Medizinprodukten<\/strong> m\u00fcssen ein Qualit\u00e4tsmanagementsystem<\/strong> (QMS)<\/strong> besitzen. Die Errichtung und Aufrechterhaltung<\/strong> von QMS<\/strong>\u00a0basierte urspr\u00fcnglich auf der Norm DIN EN ISO 9001<\/strong>. Seit dem Jahr 2003 gilt die von der EU\u2010Kommission in Auftrag gegebene und harmonisierte Norm DIN EN ISO 13485:2012<\/strong>. Die QMS von Medizinprodukte\u2010Herstellern werden in Deutschland durch staatlich Benannte Stellen<\/strong> zertifiziert<\/strong>. Nach der Erstzertifizierung<\/strong> finden j\u00e4hrliche Wiederholungsaudits<\/strong> der Benannten Stellen<\/strong> statt, gefolgt von Zertifizierungsaudits\u00a0<\/strong>sp\u00e4testens alle f\u00fcnf Jahre. Bei Erfolg stellt die Benannte Stelle die Konformit\u00e4tsbescheinigung aus.<\/strong> Erst diese Bescheinigung berechtigt den Hersteller zur Ausstellung der Konformit\u00e4tserkl\u00e4rung<\/strong> <\/a>sowie zur Anbringung der CE\u2010Kennzeichnung<\/strong> <\/a>auf sein Produkt.<\/p>

Mit der Errichtung des QMS integrieren wir auch GMP-Anforderungen (Good Manufacturing Practice). Ebenfalls soll das System schnell in die t\u00e4gliche Routine integriert werden, dann kann es die Unternehmensf\u00fchrung unterst\u00fctzen. Pharma Expertise Consulting bietet einen Audit-Service, der sicherstellt, dass Medizinprodukte die vorgegebenen Qualit\u00e4tsanforderungen erf\u00fcllen. Ebenfalls \u00fcbernehmen wir die Qualifizierung und Auditierung von Lieferanten und Lohnherstellern, Selbstinspektionen von Medizinprodukte-Herstellern und simulieren unangek\u00fcndigte Audits der Benannten Stellen, um bestehende Prozesse zu pr\u00fcfen und kontinuierlich zu verbessern.<\/p>

Wir unterst\u00fctzen Sie bei der Erstellung eines an Ihre Produktbed\u00fcrfnisse angepassten Qualit\u00e4tsmanagementsystems. Sprechen Sie uns gerne an!<\/strong><\/p>

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\"4.10.8\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_column type=\"4_4\" _builder_version=\"4.10.8\" _module_preset=\"default\" global_colors_info=\"{}\"][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\" animation_style=\"fade\" animation_direction=\"top\" saved_tabs=\"all\" global_colors_info=\"{}\"][et_pb_column type=\"4_4\" _builder_version=\"3.25\" custom_padding=\"|||\" global_colors_info=\"{}\" custom_padding__hover=\"|||\"][et_pb_text admin_label=\"Title\" _builder_version=\"4.13.0\" text_font=\"Montserrat||||||||\" text_text_color=\"#747d88\" text_line_height=\"1.9em\" header_font=\"||||||||\" header_2_font=\"Manrope|600|||||||\" header_2_text_color=\"#20292f\" header_2_line_height=\"1.4em\" text_orientation=\"center\" max_width=\"700px\" module_alignment=\"center\" animation_style=\"slide\" animation_direction=\"bottom\" animation_intensity_slide=\"4%\" global_colors_info=\"{}\"]<\/p>

Unsere Services im Qualit\u00e4tsmanagement f\u00fcr Medizinprodukte:<\/h2>

[\/et_pb_text][\/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||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>

Errichtung<\/strong> eines QMS
<\/strong>inklusive Zertifizierung
<\/strong>(z. B. ISO-13485-Zertifizierung<\/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\" hover_enabled=\"0\" 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=\"{}\" sticky_enabled=\"0\"]<\/p>

Integration<\/strong> von mehreren Anforderungen<\/strong> (Richtlinien<\/strong>, MDR<\/strong>, IVDR<\/strong>, ISO 13485<\/strong>, USA QSR<\/strong>,\u00a0Japan Ord. 169<\/strong>, Brasilien RDC 16\/2013<\/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>

Zusammenstellung<\/strong> der Dokumentation<\/strong> (unternehmensspezifische
Struktur<\/strong> und Prozesse<\/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>

Flexible QMS-Dokumentation zur schnellen Anpassung<\/p>

[\/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>

Schulung<\/strong> und Unterst\u00fctzung<\/strong> w\u00e4hrend des gesamten Zertifizierungs-<\/strong>\u00a0und\u00a0
Zulassungsprozesses<\/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>

Durchf\u00fchrung<\/strong> von Audits<\/strong> und 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=\"4.14.2\" 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>

Begleitung<\/strong> von Audits<\/strong>
durch die Benannte Stelle<\/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-3488","page","type-page","status-publish","hentry"],"yoast_head":"\nMedical devices: Quality Management System, 21 CFR 820, 13485<\/title>\n<meta name=\"description\" content=\"PEC offers: Quality management system \u2714 quality system regulation FDA 21 CFR 820 \u2714 ISO13485 \u2714 Design control \u2714 risk management ISO14971\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\/quality-management-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical devices: Quality Management System, 21 CFR 820, 13485\" \/>\n<meta property=\"og:description\" content=\"PEC offers: Quality management system \u2714 quality system regulation FDA 21 CFR 820 \u2714 ISO13485 \u2714 Design control \u2714 risk management ISO14971\u27a8 contact.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharma-expertise.com\/en\/quality-management-system\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Expertise Consulting\" \/>\n<meta property=\"article:modified_time\" content=\"2022-11-04T17:38:32+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=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/quality-management-system\\\/\",\"url\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/quality-management-system\\\/\",\"name\":\"Medical devices: Quality Management System, 21 CFR 820, 13485\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/#website\"},\"datePublished\":\"2022-03-02T12:03:52+00:00\",\"dateModified\":\"2022-11-04T17:38:32+00:00\",\"description\":\"PEC offers: Quality management system \u2714 quality system regulation FDA 21 CFR 820 \u2714 ISO13485 \u2714 Design control \u2714 risk management ISO14971\u27a8 contact.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/quality-management-system\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/quality-management-system\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/quality-management-system\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/pharma-expertise.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Quality Management System\"}]},{\"@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: Quality Management System, 21 CFR 820, 13485","description":"PEC offers: Quality management system \u2714 quality system regulation FDA 21 CFR 820 \u2714 ISO13485 \u2714 Design control \u2714 risk management ISO14971\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\/quality-management-system\/","og_locale":"en_US","og_type":"article","og_title":"Medical devices: Quality Management System, 21 CFR 820, 13485","og_description":"PEC offers: Quality management system \u2714 quality system regulation FDA 21 CFR 820 \u2714 ISO13485 \u2714 Design control \u2714 risk management ISO14971\u27a8 contact.","og_url":"https:\/\/pharma-expertise.com\/en\/quality-management-system\/","og_site_name":"Pharma Expertise Consulting","article_modified_time":"2022-11-04T17:38:32+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/pharma-expertise.com\/en\/quality-management-system\/","url":"https:\/\/pharma-expertise.com\/en\/quality-management-system\/","name":"Medical devices: Quality Management System, 21 CFR 820, 13485","isPartOf":{"@id":"https:\/\/pharma-expertise.com\/#website"},"datePublished":"2022-03-02T12:03:52+00:00","dateModified":"2022-11-04T17:38:32+00:00","description":"PEC offers: Quality management system \u2714 quality system regulation FDA 21 CFR 820 \u2714 ISO13485 \u2714 Design control \u2714 risk management ISO14971\u27a8 contact.","breadcrumb":{"@id":"https:\/\/pharma-expertise.com\/en\/quality-management-system\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/pharma-expertise.com\/en\/quality-management-system\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/pharma-expertise.com\/en\/quality-management-system\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/pharma-expertise.com\/en\/"},{"@type":"ListItem","position":2,"name":"Quality Management System"}]},{"@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\/3488","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=3488"}],"version-history":[{"count":13,"href":"https:\/\/pharma-expertise.com\/en\/wp-json\/wp\/v2\/pages\/3488\/revisions"}],"predecessor-version":[{"id":4029,"href":"https:\/\/pharma-expertise.com\/en\/wp-json\/wp\/v2\/pages\/3488\/revisions\/4029"}],"wp:attachment":[{"href":"https:\/\/pharma-expertise.com\/en\/wp-json\/wp\/v2\/media?parent=3488"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}