Regulatory Open Forum

George Samaras at Samaras & Associates - george@samaras-assoc.com
Bryant Foster at Research Collective - bryant@research-collective.com
Adam Shames at Core Human Factors - shames@corehf.com

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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
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Original Message:
Sent: 23-Jul-2019 13:43
From: Amy Fowler
Subject: ISO Recommendations for Usability/Human Factors Test Houses

Hello Everyone,

I have a client who would like to get a few quotes for the Usability/Human Factors testing FDA is demanding for his submission.  I would like to get some recommendations for test houses that do this kind of work.  Has anyone out there had a particularly positive or negative experience?  

Amy Fowler, RAC, Esquire

Pathmaker FDA Law