What is IEC 62304

‘IEC 62304’ Standard for Medical Device Software

What is IEC 62304 ?

The international standard IEC 62304. That is for medical device software – software life cycle processes. IEC 62304 is a standard which implifies life cycle requirements for the medical software development as well as software within medical devices.

IEC 62304 standard is managed by the European Union (EU) and the United States (US) and offers permission to use as a benchmark to comply with regulatory requirements within both those markets.

Every Medical Device Software Requires it.

IEC 62304.Org. We offer medical device software training and consultancy services. The international standard IEC 62304. Learn more about IEC 62304.

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