Navigate regulatory nuances for your SaMD by following a structured approach to maintain compliance post-release.
Follow this framework to ensure your SaMD conforms to HF standards post-release
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Kevin Ten Brink
Director
The foundation of Kevin’s career was formed working closely with ophthalmologists performing intricate ophthalmic surgery. This experience provided him a profound understanding of the critical importance of medical devices and their impact on patients’ lives. As a usability researcher, Kevin has further developed a unique empathy for the challenges healthcare providers face through extensive ethnography and contextual inquiry in operating rooms around the world. Driven by the desire to make a tangible difference, Kevin finds motivation in the positive transformation UX and HF research brings to the lives of patients and medical professionals alike.
Kevin has a successful track record of launching complex devices both in the US and international markets, highlighting his exceptional ability to navigate the intricate landscape of global regulatory requirements while addressing the diverse needs of healthcare systems around the world. With over 13 years of experience, Kevin is a frequent presenter at conferences and collaborator in the medical technology human factors landscape. Kevin has a BS in Physiology from Michigan State University and an MBA from University of Phoenix.
Bold facts
Learn more about
Kevin
Something unique about you summed up in one sentence:
I have a dog that appeared in a commercial aired during the Super Bowl.
In your spare time (or if you had spare time), you would absolutely do this:
Spend more time in the mountains on my bike.
Your ultimate celebrity dinner party guest list would include...
I think it would be fun to hang out with professional comedians in a social setting (e.g., Dave Chappelle, George Carlin, Ali Wong, Chelsea Handler).
You cannot start the day without doing this...:
Preparing and drinking coffee.
Favorite book:
How to Win Friends and Influence People.
Favorite quote:
"Life is 10% what happens to you and 90% how you react to it".
What superpower would you most want?
I think the ability to be invisible would be very handy when conducting in-field usability research.
What fictional family would you like to join?
I would like to join the Skywalker family; very interesting family dynamic.
Read Kevin's bold insights
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