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April 21, 2020
FDA released a new guidance document titled, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments, Guidance for Industry and Food and Drug Administration Staff.  This guidance was issued on April 22, 2020.  The background on the guidance states, “Timely nonbinding feedback can help device firms determine whether proposed actions to address inspectional observations are...
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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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