Day

August 7, 2021
The US FDA released the 2022 user fees for certain medical device submissions and establishment registration. On August 2, 2021, the FDA announced the FY2022 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2022. FY2022 User fees are required for the following types of medical device submissions:...
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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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