Human Factors Engineering to Satisfy the New IEC 62366-1, -2 is an event dedicated to new medical device usability standard, IEC 62366-1:2015, "Usability Engineering in IEC 62366-1:.
Topics
- Written for easier to understand intent / implementation
- Key parts of IEC 62366-1
- Closer ties to ISO 14971, Medical Device Risk Management
- Part 1 focuses on "what", Part 2 on "how"
- Planning requirements
- Closer adherence to US FDA guidance; more harmonization
- User interface considerations
- Defined engineering process
Who should Attend
- Middle Management
- Senior Management
- Operations
- QA/RA
- Engineering
- Production
- Medical Device Consultants
- Marketing
