SWEREF-604

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IEC 62304

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SWE-220,

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IEC 62304 – medical device software – software life cycle processes1 is an international standard published by the International Electrotechnical Commission (IEC),

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The standard specifies life cycle requirements for the development of medical software and software within medical devices. It has been adopted as national standards and therefore can be used as a benchmark to comply with regulatory requirements.