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

UK Responsible Person Services

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

Workshop: Software as a Medical Device (SaMD) in Zürich

Interpellation Jacqueline de Quattro on medical devices

Web based tool to analyze effect of significant changes to devices covered by MDD or AIMDD certificates

Politics intervene regarding medical devices

Swiss Medtech Umfrage: Export in die EU mit Drittstaatanforderungen sichern

Peter Studer joins confinis as Senior Advisor

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

#MDR – Transition periods and definitions

Work in progress: MDR implementation – impact on your Quality Management System (ISO 13485:2016)

Your insight to: confinis and its partners – work in progress regarding MDR implementation

WORKSHOP: PMS under the new European MDR