2 docs tagged with "qms"

MDR 2017/745, Annex IX and IVDR 2017/746, Annex IX. Annex IX is the most widely used conformity assessment route for Class IIa, IIb, III (MDR) and Class B, C, D (IVDR). It is the only permitted route for Class III (MDR) and Class D (IVDR).

MDR Annex II, Section 3 and IVDR Annex II, Section 3. This section of the technical documentation covers how the device was designed and how it is manufactured — the information necessary to ensure reproducibility and traceability.