Thursday, 6 December 2018
5:30-8:00 pm PST
210-4321 Still Creek Drive
Burnaby, BC V5C 6S7
+1 604 293 2266
In recent years, US and global regulatory agencies have placed greater emphasis on human factors requirements for medical devices and combination products. The FDA’s Human Factors Engineering guidance and IEC 62366-1:2015 detail the process manufacturers must follow. However, due to great diversity in the devices being created, many struggle to understand how the regulations should be applied to their specific devices. This interactive presentation will help simplify the human factors process by breaking it down into three main activities: identification, formative research and validation testing.
Topics to be discussed include:
- how human factors fits into product development and design controls
- description of the costs associated with human factors studies
- strategies for identifying device users, use environments and critical tasks
- methodological differences between generative, formative, and validation/summative studies
- how to write up positive and negative results from human factors studies
The engagement activity is brought to you by the RAPS Vancouver chapter and is intended to promote professional development and networking opportunities in the local regulatory community. Dinner will be available to all attendees and RAC holders may claim two RAC recertification credits.
Bryant Foster, MS, vice president, human factors and user experience, Research Collective
RAPS Member: $25