ISO 14971:2019 & Europe MDR Risk Management Process Flow

Trying to understand the “state of the art” in medical device risk management?
This diagram attempts to distinguish between ISO and European requirements.

Lazzara MD RM Chart 2019+MDR.png

Here is a link to the diagram in PNG format.

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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