I strongly recommend Agilis Consulting ( agilisconsulting.com). They have been working in the human factors field since before it became known to most folks that it was important, and have navigated the testing and submission/approval process many times. From personal experience, they are also great people to work with. They will get it right the first time...
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Christopher Jordan RAC
Senior Director, Regulatory Affairs
Zionsville IN
United States
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Original Message:
Sent: 05-Mar-2018 13:48
From: Anonymous Member
Subject: Human Factors testing
This message was posted by a user wishing to remain anonymous
We are developing a drug/device combination product for approval in the US under a 505(b)(2) application. Part of the approval will depend on the results of a Human Factors study. I am looking for a company or consultant that can help prepare a risk assessment, perform the studies, and write a final report, as required by FDA. Who would you recommend?