Day

August 2, 1999
Linweld 8/2/99 Significant deviations include, but may not be limited to the following: Failure to maintain a computer system with validated program capabilities for operating a medical gas facility [21 CFR 1-11.68]. Examples include: No testing of the system after installation at the operating site. Operating sites are part of the overall system and lack...
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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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