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ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
See
https://www.iso.org/committee/54892.html
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971:2019 Medical devices — Application of risk management to medical devices