Glossary · Regulation
ISO 14971
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 14971 is the international standard for risk management of medical devices, including software, across the whole life cycle from design to post-market use.
Manufacturers identify hazards, estimate and control risks and judge whether the remaining risk is acceptable; IEC 62304 and EU MDR conformity rely on it.
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Definitions written by Anpheros from the official sources linked on each page. General information about standards and regulation, not legal or medical advice. All terms →