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ISO 13485 toolkit
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UNE EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) - European Standards
ISO 18113-1 - European Standards
ISO 20417:2021(en), Medical devices — Information to be supplied by the manufacturer
ISO: 14971 Quality risk management of medical devices
Understanding the International Standard for Risk Management of Medical devices ISO 14791
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ISO/TR 20416:2020(en), Medical devices — Post-market surveillance for manufacturers
