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Can I Use AI in Medical Device Regulatory?
I ain’t no Luddite. I was an early adopter of AI/ML and have been implementing API keys into my source code since 2022. But BEWARE: AI (Grok, ChatGPT, etc) constantly makes mistakes in subjects of medical device regulatory.
Try this experiment: Consider a medical device that already has a 510(k). Now ask your favorite AI chatbot what that given medical device’s 510(k) number is. I bet it gets it wrong more than 30% of the time. Ask AI to give you predicate recommendations. It will probably get that wrong 50% of the time. AI is an incredible tool, but do not trust it with important work (especially with proprietary information). I absolutely love this blossoming technology, but it can make grave mistakes in a field that requires 100% precision.
AI may one day rule us all, but until it can get a simple 510(k) number correct, that day will not come.
Don’t let missed information delay the launch of your device.
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About The Author
Isaac Erickson
Isaac A Erickson, MBS, President of IMDS Consulting, has over 15 years experience combining technical proficiency with in-depth regulatory knowledge to drive innovation in a global landscape.
Recent Articles
AI use in Medical Device Regulatory?
December 15, 2025
