Swiss MPC

EU MDR IVDR FDA Clinical Evaluation Cybersecurity

Swiss MPC is a regulatory consultancy based in Cham, Switzerland, serving medical device and combination-product manufacturers. Its services include EU MDR and IVDR strategy, CE-marking documentation, FDA submissions, quality systems and clinical evaluation. The team also supports software lifecycle documentation and cybersecurity, UDI implementation, product development and post-market obligations, with projects led by senior consultants.

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Clinical Evaluation: Post-Market Surveillance (PMS) Database Search

Dr. Oliver Eidel

32 views · 8 months ago

Is ISO 13485 certification required before CE marking for software medical devices in the EU and Switzerland?

Anonymous · 1 comment

6 months ago

We want to certify our software as a medical device in the EU and Switzerland. I have two questions: • Is it necessary to first obtain ISO 13485 certification before applying for CE marking? What are

Accepted 4 answers

For your first question: MDR requires manufacturers to establish a QMS (Quality Management System), as stated in Article 10 MDR. For class IIa devices

Getting Started

EU MDR: Step-By-Step Guide To Becoming Compliant

Updated 9 months ago

Dr. Oliver Eidel