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