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July 26, 2022
Recently, a new cybersecurity standard, IEC 81001-5-1:2021, Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle, was released.  As the name implies, this standard addresses the overall software development lifecycle (SDLC) with regard to cybersecurity activities.  For medical device manufacturers, this is very...
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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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