Day

March 11, 2003
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. At AAMI's International Standards Conference on March 11 2003 FDA's CDRH Software Compliance and Part 11 Representative (John Murray) gave the first presentation on FDA's changes in its approach to Part 11.  The slides from this presentation can be...
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This content is only available to Premium Level or higher subscribers.  See our Subscribe page for information on subscriptions. At AAMI's International Standards Conference on March 11 2003 FDA's CDRH Software Compliance Expert and AAMI Software Committee co-chair (John Murray) gave a presentation on FDA's software message and the role standards can play to benefit industry and...
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Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

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Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • 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.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

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