{"id":14105,"date":"2023-03-26T08:14:59","date_gmt":"2023-03-26T08:14:59","guid":{"rendered":"https:\/\/staging.amb.se\/?page_id=14105"},"modified":"2023-11-14T20:15:58","modified_gmt":"2023-11-14T20:15:58","slug":"quality-management-in-medical-technology","status":"publish","type":"page","link":"https:\/\/staging.amb.se\/en\/dictionary\/quality-management-in-medical-technology\/","title":{"rendered":"Quality management in medical technology"},"content":{"rendered":"

[vc_row][vc_column css=”.vc_custom_1696960813491{margin-left: -15px !important;background-color: #ffffff !important;}”][spacer height=”20″][vc_column_text css=”.vc_custom_1699992957464{padding-right: 50px !important;padding-left: 50px !important;}” el_id=”ordlista-las-mer”]<\/p>\n

Quality management in medical technology<\/h1>\n

In order to meet the safety and performance requirements of the EU Regulation (MDR) for medical devices, there are various quality assurance standards such as ISO 9000\/9001 and in particular ISO 13485 which establish the requirements for a quality management system for organizations and actors operating in one or more parts of the life cycle of a medical device.<\/p>\n

Similar concepts:<\/h2>\n

MDR<\/a>
\nRegulatory requirements<\/a>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column css=”.vc_custom_1696960875631{margin-top: 10px !important;}”][vc_column_text css=”.vc_custom_1698257499356{margin-top: -20px !important;padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 30px !important;background-color: #ffffff !important;border-radius: 5px !important;}” el_id=”ordlista-las-mer”]<\/p>\n

Read more:<\/h2>\n

|<\/strong> ISO <\/strong>13485:2016 (new page)<\/a><\/h3>\n

Knowledge blog:<\/h2>\n

|<\/strong> What is quality management in medical technology?<\/a><\/h3>\n

|<\/strong> How do I give my medical device a CE mark?<\/a><\/h3>\n

[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

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