FDA ADVAMED Part 11 Guidance Presentation

On 10/23/03 Joe Famulare leader of FDA’s Part Redirection committee gave a talk on the final guidance at an Advamed conference. A copy of his slides are at the link provided.

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Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact training@softwarecpr.com

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