IEC 62304 For Software Lifecycle In Medical Device

IEC 62304 (and EN 62304) is the international standard for software life cycle for medical device. IEC 62304 specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union and the United States. Compliance with this standard fulfills the FDA 21 CFR820 requirements as well as the Medical Device Directive 93/42/EEC.

Main activities described in IEC 62304 that are fully supported in QPack

  • Requirements traceability
  • Integrated risk management process
  • Test Management (Unit/Module/Integration/System)

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