Hello Kathryn,
There are a few Usability and usability engineering firms out there, unfortunately would not be able to provide any recommendation, but just wanted to comment making sure they can do everything you need. There are some companies specialised in more front-end activities like Human Factors Engineering (HFE) or Usability Engineering from a design perspective. If you are looking at a Summative Evaluation there are some companies set-up to do in-house usability testing such as non-clinical and more just interacting with the device. Then there are others which can specialise in more clinical trial type usability study where it is used with/on/by humans.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Apr-2022 01:58
From: G Ferriere
Subject: Recommendation for Vendor: Summative Evaluation
Hello Kathryn,
I have worked with Pat and Shannon at Agilis before. They had done joint training with U.S. FDA on the human factors study.
https://www.agilisconsulting.com/patricia-patterson
I have another vendor as well if you want to get different quotes to compare but we decided to use Agilis.
Gina
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G Ferriere
Monterey Park CA
United States
Original Message:
Sent: 22-Apr-2022 11:46
From: Kathryn Stager
Subject: Recommendation for Vendor: Summative Evaluation
Does anyone have any vendors they'd recommend for conducting a summative evaluation of a US Class II medical device? Thank you!
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Kathryn Stager RAC
VP of Regulatory Affairs and Quality Systems
Beachwood OH
United States
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