Regulatory Resources
Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools
ISO 13408-1:2008/AMD1:2013 — Aseptic processing of health care products — Part 1: General requirements
ISO 14644-1:2015 — Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration
ISO 5840-1:2021 — Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
ISO 14630:2012 — Non-active surgical implants — General requirements
ISO 22442-3:2007 — Medical devices utilizing animal tissues — Part 3: Validation of the elimination and/or inactivation of viruses and TSE agents
ISO 22442-1:2020 — Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
ISO 20417:2021 — Medical devices — Information to be supplied by the manufacturer
ISO 15223-1:2021 — Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
ISO 17665-1:2006 — Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control
ISO 11737-1:2018 — Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
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