Areas Covered in the Session :
- Understanding IEC 62304
- Design Control
- Configuration management
- Software validation more than testing
- Requirements traceability
- Risk analysis
- Unit, integration and system testing
- Algorithm validation
- Challenges to the software
Who Should Attend:
- Quality Assurance Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Validation Departments
- Software Developers
- Software Engineers
- IT Personnel
- Device Development Managers
- Systems engineers responsible for developing requirements
- Test Engineers
- Quality System auditors
- Engineering managers and personnel
- Everyone tasked with product, process, software validation responsibilities