What is PD IEC/TR 80002-3 - Software life cycle processes for medical devices about?
PD IEC/TR 80002 is a technical report that discusses medical device software. Provides the reference model of medical device software life cycle processes to ensure the safety and effectiveness of a medical device containing software.
PD IEC/TR 80002-3 is the third part of a multi-part series that provides the description of software life cycle processes for medical devices.
The medical device software life cycle processes under PD IEC/TR 80002-3 are derived from IEC 62304:2006, with corresponding safety classes. They have been aligned with the software development life cycle processes of ISO/IEC 12207:2008 and are presented herein in full compliance with ISO/IEC 24774:2010. The content of these three standards provides the foundation of this TR.
Who is PD IEC/TR 80002-3 - Software life cycle processes for medical devices for?
PD IEC/TR 80002-3 on software life cycle processes for medical devices is useful for:
- Engineer and developer of medical device software
- Test centres
- Regulatory authorities
Why should you use PD IEC/TR 80002-3 - Software life cycle processes for medical devices?
Software is often an integral part of medical device technology. Establishing the safety and effectiveness of a medical device containing software requires well-designed software that fulfils its purpose without causing any unacceptable risks.
PD IEC/TR 80002-3 guideline assists you with the software development process, software maintenance, software risk management, software configuration management, and software problem resolution for medical device software life cycle processes.
With obedience and compliance to PD IEC/TR 80002-3, you can standardise the safety and effectiveness of a medical device containing software and assist in designing software that fulfils its purpose without creating hazards.