Day

December 29, 2021
What is CAPA?   Corrective and Preventive Action (CAPA) is a fundamental quality process for medical device manufacturers including SaMD.  From the regulations it is really not that complicated.   21 CFR 820.100 reads: (a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for: (1)...
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When developing medical devices, a manufacturer may have difficulty knowing when (or what) the transition from research phase activities to design controls has begun.  Often this is due to the nature of research itself - one is exploring a concept or design approach that may or may not pan out in the end.  The US...
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Latest News!

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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