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Comparison Matrix FDA QSR 21CFR 820/ISO 13485:2016
Important notice regarding the matrix – it refers to the current FDA QSR 21CFR 820 and not to one to come. FDA-QSR-21CFR-820 ISO 13485 § 820.1 – Scope. 1 Scope 820.5 Quality System
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FDA QSR 21CFR 820 Transition to ISO 13485:2016 – FAQ
The FDA has come up with the initiative to harmonize FDA QSR 21CFR 820 with the ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes. The goal is to
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