The post provides a brief overview of the medical device usability standard, the importance of a Usability Engineering Process, and how it better aligns with the FDA Draft Guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design.
Archives for August 2015
“to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising.” (pp. 43093-43094)
The two-day event will be September 29th and 30th at the FDA White Oak Campus in Silver Spring Maryland. For those that can’t attend in person, a webcast will be available.