Regulatory Resources
Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools
ISO 10993-10:2021 — Biological evaluation — Part 10: Tests for skin sensitization
ISO 10993-6:2016 — Biological evaluation — Part 6: Tests for local effects after implantation
ISO 10993-5:2009 — Biological evaluation — Part 5: Tests for in vitro cytotoxicity
ISO 10993-4:2017 — Biological evaluation — Part 4: Selection of tests for interactions with blood
ISO 10993-3:2014 — Biological evaluation — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-1:2018 — Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 14155:2020 — Clinical investigation of medical devices for human subjects — Good clinical practice
IEC 81001-5-1:2021 — Health software and health IT systems safety, effectiveness and security — Part 5-1: Security
IEC 82304-1:2016 — Health software — Part 1: General requirements for product safety
IEC 62366-1:2015/AMD1:2020 — Medical devices — Application of usability engineering to medical devices
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