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?

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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!

Webinar on Guidance Available

Differences between 2011 and 2016 guidance on human factors
Presented by ComplianceOnLine
First Presented, April 26, 2016

Priority Device List

FDA issues new guidelines.
See Standards and Guidances.
February 2016