Earlier this year, FDA released the "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" Draft guidance.
With increasing emphasis, regulated agencies, including the FDA, are requiring medical device manufacturers to be more diligent in making sure they meet the expectations of usability of devices to reduce use error, injuries and product recalls. Human factors activities are required to accomplish this, such as identification of use related hazards, designing out hazards, usability evaluations and validation testing.
During this 90 minute webinar, Jason Fouts, Stephanie Seraphina and Kari Rice, a team of experienced human factors engineer consultants from the Mobia Group, will present information and methods to help you understand what is expected and how to address regulatory expectations related to human factors and usability. Special emphasis will be placed on the new human factors guidance document recently published by the FDA; 60601-1 3rd Edition and IEC62366 will also be discussed.
Attendees will hear what is expected for human factors activities and deliverables throughout the product development process. Real world examples will be provided. The main focus of this webinar will provide you with the information and tools you need to learn how these items can be accomplished during product development.
Key topics include:
- Intended device users, uses, use environments, and training
- Device user interface and summary of known use problems
- User task selection, characterization and prioritization
- Summary of formative evaluations and Validation testing
- FDA expectations, 60601-1 3rd Edition
- IEC62366 (Medical devices – application of usability engineering to medical devices)
For one low price, you and your entire team can take part in this fast-paced, insightful webinar. Best of all, you’ll be able to connect personally with our speakers when we open up the phone lines for live Q&A.