[KongchangAI]
Unverified50% confidenceFactExact time

All compliant eQMS solutions design version binding to be non-retrospective, and its regulatory roots lie in the requirements of ISO 13485 §7.5 and 21 CFR 820.40 for controlled documents and record integrity.

1
Sources
50%
Confidence
Long-term
Relevance
10/13/2026
First Seen

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