A “traditional” risk assessment does not meet the needs of FDA-required human factors analyses.
Is FMEA inadequate for human factors analyses?
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Patrick McCormack
Director
Patrick has 10 years of experience applying HFE/UE to the development of medical devices with an emphasis on ensuring safe and effective use as part of the FDA approval process. He possesses expertise in the interpretation and implementation of various design standards, including IEC 62366, AAMI HE75, BS EN ISO 14971, and others. Patrick has a BS in Human Factors Psychology from Embry-Riddle Aeronautical University.
Bold facts
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Patrick
What is your favorite way to give back to the community?
I love coaching high school cross country. Helping kids navigate awkward years through running is one of the most rewarding experiences I’ve had.
What fictional universe would you like to live in?
Being a Jedi master would be pretty cool, but the lifestyle seems a little stressful with the Empire constantly doing Empire things.
In your spare time (or if you had spare time), you would absolutely do this:
Learn to play guitar. The “guitar guy” at the party always seems so cool.
Your favorite city in the world is...and why?
Key West. It’s always fun at the end of US-1.
You cannot start the day without doing this:
Going for a run! It’s great to start the day with a little movement and fresh air.
Your ultimate celebrity dinner party guest list would include:
Mario Andretti, Jason Isbell, Ernest Hemingway, and Des Linden. At a minimum, we would have some good tunes and interesting conversation!
Long-term personal or professional goal?
I would love to run every World Marathon Major (Boston, New York, Chicago, Berlin, Tokyo, and London). I ran Boston in 2022.
Any other facts to share?
We are a crazy dog family with two dogs of our own, and foster dogs that rotate through the house.
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