Regulatory Resources
Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools
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
ISO 11607-2:2019 — Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11607-1:2019 — Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11137-2:2013/AMD1:2023 — Sterilization — Radiation — Part 2: Establishing the sterilization dose
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