Day

October 25, 2016
A final draft (FDIS) of “IEC 82304-1: Health software – Part 1: General requirements for product safety” has been approved. The standard will be published after final editing. This is expected around the end of the year (2016). The primary focus of this standard is on requirements for the developers of the software product. It...
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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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