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February 25, 2019
What does one need to know about IEC 62304? In our 3-day 62304 Training course, we flow through the software development lifecycle drawing attention to requirements of the standard as well as related standards and always current FDA expectations from our experience.  The topics we plan to cover in our 2019 course are below. Topics: Regulatory...
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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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