The Medical Device Regulation and the medical care for children and rare diseases

confinis partners with Irdeto to launch the first cybersecurity assessment tool in the medical devices industry

confinis offers Swiss Representative Service

Exporting Swiss Medical Devices to the EU

Join our Startup Workshop 2021!

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

Bei Medizinprodukten auf die EU warten hilft der Schweiz wenig

Revision der Schweizer Medizinprodukteverordnung mit Folgen

Interpellation Jacqueline de Quattro on medical devices

Politics intervene regarding medical devices

EU MDR audit requirements and links to MDSAP program

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

Technical Documentation for medical devices under the new European MDR

Conformity Assessment Procedures and Premarket Scrutiny under EU MDR

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