Europe MDR & IVDR on Steroids

Thank you, NAMSA, for preparing this amazing document!

NAMSA Reg Tool.png

Per NAMSA, provided within this document are:

  • Bookmarks for each Article and Annex
  • Links to where the Regulations reference another section of the document
  • Links to other cited Regulations, Directives, documents or websites
  • European Commission Fact Sheet

The internal links is what makes this version especially valuable.

Now, we will have a chance of understanding these regulations (I suppose).

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.

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