TRAINING

Theory and practice of Software life-cycle processes according to IEC 62304 is explained. The course is aimed at developers, QA & RA professional, and certification bodies.
Medical device software – Software life-cycle processes according to EN 62304
(Intermediate to Advanced level – 8 to 16 hours course)
- Field of application
- Purpose
- Software life cycle processes
- SOFTWARE DEVELOPMENT LIFE CYCLE MODELS
- Process/Activity/Task
- Software safety classification
- 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
- Software maintenance PROCESS
- Software RISK MANAGEMENT PROCESS
- Software configuration management PROCESS
- Software problem resolution PROCESS
- Amendment IEC 62304/A1:2015-06