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ISO 9001:2026 and the medical device shop — does it change anything, or is it a footnote to 13485?

This story is from 2026-09-20. It is preserved in the archive; the latest stories are on the live feed.

We hold both. ISO 13485 was the audit we prepped for weeks in advance. ISO 9001 was the one we prepped for the morning of, because the 13485 evidence covered most of it already. That's been the pattern for our Class II setup, and from what I can tell talking to peers at other 200-ish person manufac…

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  1. 2026-09-20 02:02 · DEV Community — AI
    ISO 9001:2026 and the medical device shop — does it change anything, or is it a footnote to 13485?

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