Streamlining your FDA human factors approval process.
You know that the FDA requires Human factors for the approval of most medical devices and combination products.
How will you comply with these requirements in an expedient manner, avoiding costly delays in the approval process?
Do you have the evidence necessary to demonstrate that your device design has addressed use risk problems?
How do you collect this evidence, and how should it be presented to facilitate a problem-free review by FDA?
Call us for a free 30 minute discussion about how we can help you with these questions!
Learn how to navigate the FDA post-market databases to identify key usability issues with marketed medical devices and combination products!
March 27, 2019
Bob North and Ron Kaye, FDA Guidance author, will be leading a three day workshop focused on user testing, use-risk assessment, and responding to FDA questions and requests.