Medical Device Industry Seminar & Reception

Wednesday, February 16, 2021
2 - 5 pm (USFDA Speakers and Interactive Panelist Discussion)
5 - 7 pm (Reception)
North Carolina Biotechnology Center
5 TW Alexander Drive
Location Map

$25 per person
(Those who register may attend one or both parts)

Hosted by—
Wake County Economic Development
NC Medical Device Organization

The forum will feature speakers from the USFDA, Peter B. Carstensen and Ron Kaye, who will discuss human factors engineering design standards for medical devices and other related topics, an interactive panelist discussion, and an evening reception.

Peter B. Carstensen, Senior Systems Engineer
Center for Devices and Radiological Health (CDRH)
Food and Drug Administration

Mr. Carstensen, a 1960 graduate of the Polytechic Institute of Brooklyn, is a senior systems engineer specializing in human factors. He developed a keen interest in human factors engineering early in his aerospace career where he worked as systems analysis and integration engineer before joining the FDA’s Bureau of Medical Devices in 1974.

He has been actively involved for more than 30 years in national and international standards writing committees for medical devices where he represents FDA’s interests. He is currently the Convenor of IEC SC 62A, Working Group 5, Ergonomics and Symbols and Convener of IEC-ISO Joint Working Group 4, Usability and represents FDA’s Center for Devices and Radiological Health on several AAMI, ASTM and IEC and ISO medical device standards committees dealing with anesthesia and respiratory equipment and human factors engineering.

Ron Kaye, Human Factors Specialist
Center for Devices and Radiological Health (CDRH)
Food and Drug Administration

Mr. Kaye’s work focuses on safety of medical equipment with respect to use issues including research on device use-safety issues, participation in national and international standards and guidance development and outreach to professional communities and medical device users. He has a Masters Degree in Applied Psychology and has worked in Human Factors for 20 years. Prior to coming to the FDA he worked with power plant control rooms, military weapons and communications systems, aircraft cockpit and air traffic control instrumentation as well as medical devices.

Register Now—
RSVP by February 11. No refunds after deadline: ~ Register

Call John Nelms at 919.664.7048 or email

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