Glossary · Regulation
IEC 62304
Medical device software, software life cycle processes
IEC 62304 is the international standard for the life cycle of medical device software: planning, requirements, architecture, verification, release and maintenance, with safety classes A, B and C by the harm the software could cause.
Notified bodies expect it as evidence under the MDR; it describes process, not product features.
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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 →