Why Should You Attend:
IEC 62366 is the international standard that covers the application of usability engineering to medical devices. This standard helps medical device manufacturers consider human factors by offering a standardized 9 stage process for analyzing, specifying, developing, and evaluating the usability of their medical device, and document the process and results. This standard would satisfy the human factors requirement of the US FDA. It presents a 9 step methodology to perform and document User/Human Factors Engineering, with a focus on the typical human user.
Agenda
- Key parts of IEC 62366-1:2015 and -2:2016 - Use Engineering /
- FDA’s Human Factors Engineering
- IEC 62366m Part 1 focuses on “what”, Part 2 on “how”
- More harmonization - US FDA, ISO 14971 and IEC 62366
- Role in Design Control (21 CFR 820.30)l, Design and Development Planning (ISO 13485 7.3)
- Planning requirements
- The defined engineering process
- “Interface” defined
- User interface considerations
- Formative and Summative Evaluations and their Verification and Validation Equivalents
- Software considerations
- Suggested documentation - a Use Engineering File.
Who Should Attend
- Senior Management
- Middle Management
- QA/RA
- Operations
- Production
- Engineering
- Marketing
- Medical Device Consultants
