The FDA 21 CFR 820 Quality System has been amended to align with ISO 13485:2016. Medical Device Manufacturers will need to significantly update their Quality Management System if they are not ISO… | Kristine W.
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The FDA 21 CFR 820 Quality System has been amended to align with ISO 13485:2016. Medical Device Manufacturers will need to significantly update their Quality Management
The FDA 21 CFR 820 Quality System has been amended to align with ISO 13485:2016. Medical Device Manufacturers will need to significantly update their Quality Management System if they are not ISO 13485 compliant or certified. The new FDA QMSR will become law in the U.S. on February 2, 2026.
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