Design an AI-enabled software as a medical device that offers cutting-edge capabilities and earns the trust of healthcare professionals, ultimately improving patient care.
5 tips for designing AI-enabled SaMD that HCPs trust
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Andrew Zawisza
Quality Director
Andrew has 10 years of experience in the medical device industry in various roles within quality assurance and regulatory affairs. During this time, he led preparation efforts for a successful first-time FDA inspection, research efforts to support 510(k) submissions, and investigation and resolution of product and process deficiencies. He also implemented statistical methods and lean tools to improve process efficiency. This experience has provided him with a unique perspective on how a quality system can be an effective tool for any company. At Bold Insight, Andrew is responsible for the development and maintenance of our quality system, ensuring the continuous improvement of our processes and the quality of service we provide our clients. Andrew holds an BS in Bioengineering from Michigan State University.
Bold facts
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Andrew
Something unique about you summed up in one sentence:
Is it still unique if I Google it?
Your favorite part of working at Bold Insight:
The people… it’s a culture of friendship, fun, and passion.
In your spare time (or if you had spare time), you would absolutely do this:
Spend a summer in Alaska, (attempt to) build a house, or take a trip to space.
How long have you been in the UX field?
Quality for 10+ years, UX for 5+ years
Your favorite city in the world is...and why?
Montezuma, Costa Rica… it’s not really a city but it’s completely untouched by mainstream tourism.
Your ultimate celebrity dinner party guest list would include:
Larry David, Natalie Portman, John Oliver
Long-term personal or professional goal?
Write a book that people I don’t know will read.
Any other facts to share?
I’m INTJ
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