Blog on Medical Device Regulation and CE Marking

The role of a PRRC under the EU MDR & IVDR

12.09.2023 Knowledge

The role of a PRRC under the EU MDR & IVDR

Medical device regulatory strategy – US vs. EU

14.08.2023 Knowledge

Medical device regulatory strategy – US vs. EU

Regulatory guide to Procedure Packs, Systems, IVD Kits, and Configurable devices

30.07.2023 Knowledge

Regulatory guide to Procedure Packs, Systems, IVD Kits, and Configurable devices

Annex XVI and EU MDR – Guide to regulation of products without intended medical purpose

03.06.2023 Knowledge

Annex XVI and EU MDR – Guide to regulation of products without intended medical purpose

Medical device software (MDSW) under EU MDR and IVDR

13.05.2023 Knowledge

Medical device software (MDSW) under EU MDR and IVDR

Swiss authorised representatives for medical device manufacturers

28.04.2023 Knowledge

Swiss authorised representatives for medical device manufacturers