For a medical device/IVD manufacturer, is it mandatory for suppliers (both key components/non-key components) to be 21 CFR 820 QSR compliant/ISO 13485 certified??
For a medical device/IVD manufacturer, is it mandatory for suppliers (both key components/non-key components) to be 21 CFR 820 QSR compliant/ISO 13485 certified??
ISO13485 may be a very good certification to have, particularly for critical suppliers, but I can think of only one obscure situation (for private label devices in Canada) where it would be construed to be mandatory.
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