IEC 62304 General Requirements Training

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.

General Requirements Training

“General Requirements” is the first step of IEC 62304 standard. We offer 2 days training course on general requirements. Mainly, it covers 3 main phases such as;

  • Quality management system
  • Risk management
  • Software safety classification

Course recommended for:

  • Healthcare managers
  • Nurses & Physicians
  • Healthcare facility managers
  • All healthcare professionals
General requirements training

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