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IEC 62304
IEC 62304 – Medical Devices

medical device software – software life cycle processes[1] is an international standard published by the International Electro-technical Commission (IEC). 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.

IEC 62304 – Software Development Process
  • Software development planning

  • Software requirements analysis

  • Software architectural design

  • Software detailed design

  • Software unit implementation and verification

  • Software integration and integration testing

  • Software system testing

  • Software release


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