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Add checklist for the FDA General Software Guidance document #59

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johndgiese opened this issue Sep 2, 2020 · 0 comments
Open

Add checklist for the FDA General Software Guidance document #59

johndgiese opened this issue Sep 2, 2020 · 0 comments

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@johndgiese
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We will slowly add checklists for a few different FDA Guidance documents. Requirements in guidance documents will likely be less clearly defined than in ISO standards.

It may also be useful to extend the checklist format a bit so we can keep the documents simple. In particular, it may be nice to include lines like:

FDASG:4.2==62304:5.1.3 Optional comment goes here

to indicate that meeting this part of 62304 also meets the related guidance requirement.

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