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What Is IEC 62304?

IEC 62304 is an international standard published by the International Electrotechnical Commission (IEC) that specifies life cycle requirements for the development of medical software and software within medical devices.

Related terms: standards compliance, static analysis, tool qualification, traceability, verification

Assumption of Use: Examples in Context

A medical device manufacturer follows IEC 62304 standards to develop safe and reliable medical devices.

A software development team uses IEC 62304 to produce the required documentation to streamline the compliance and certification processes for Class I, II, and III medical devices.