23 - 25 Feb 2021 • 

2021 SoftwareCPR IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software


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Estimated Turnout

100 - 500


Feb 2021


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This three-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares .. Read more and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366). Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).



Sr. Software QA Engineer at Dexcom

San Diego, United States
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