How does the notified body assess your clinical evaluation?

How to perform a clinical evaluation for Medical Device Software

How to ensure sufficient clinical evidence for legacy devices

How to claim an equivalence in the clinical evaluation under the MDR

Revision der Schweizer Medizinprodukteverordnung mit Folgen

EU MDR audit requirements and links to MDSAP program

From “Essential Requirements” to “General Safety and Performance Requirements” – EU MDR 2017/745

Classification of medical devices under the European Medical Device Regulation 2017/745

MDR Article 117 – a look into the Crystal Ball (Part 5)