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.
- 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.