IEC 62304 Effect of safety classification on required development process documentation
What is ?
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.
Effect of safety classification on required development process documentation
We offer 2 days training on software development process in IEC 62304. It covers 9 main phases such as;
- Software development planning
- Software requirements analysis
- Software architectural design
- Software detailed design
- Software unit implementation
- Software unit verification
- Software integration and integration testing
- Software system testing
- Software release
Course recommended for:
- Healthcare managers
- Nurses & Physicians
- Healthcare facility managers
- All healthcare professionals