Did you notice that the published regulation does not have a table of contents or bookmarks?
The regulation posted to the Europa website does not include a Table of Contents or Bookmarks.
Click this link to get a version that includes a TOC and Bookmarks.
DISCLAIMER: As of the date of this posting, I have not verified the accuracy of the TOC or Bookmarks, hence the risk of use has not been reduced as far as possible.
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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