Manufacturers wishing to place medical devices on the EU market must “establish, document, implement, maintain, update and continually improve a Quality Management System (QMS)“.
The implementation and maintenance of a QMS are requirements for placing Medical Devices and In Vitro Diagnostic (IVD) medical devices on the EU market, according to the MDR (EU Medical Devices Regulation 2017/745) and IVDR (EU IVD Regulation 2017/746), respectively. Articles 10 and Annex IX of each regulation list the minimum aspects to be addressed by the QMS.
At AKRN, our expert quality consultants can support medical device manufacturers in developing and implementing a QMS under ISO 13485:2016, in compliance with EU regulations. Our services include:
- Development of QMS documentation according to ISO 13485:2016
- Full implementation of QMS according to ISO 13485:2016
- Internal audits according to ISO 13485:2016
- Gap assessments with prior ISO 13485 versions and EU requirements
- Assistance in resolving gaps identified.
