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Biocompatibility Challenges in New Material Selection for Medical Devices
Choosing the right material for a medical device goes far beyond engineering performance—it determines regulatory risk, time-to-market, and patient safety. From unexpected leachables to shifting FDA expectations, biocompatibility challenges can derail even the most innovative designs.
Explore how proactive strategies and expert consulting can turn material selection from a hidden risk into a competitive advantage.
Pat Bhatt
Sep 174 min read


Using Natural Language Processing to Map Regulatory Guidance to Device Development
Regulatory guidance is full of answers—if you can find them. See how Natural Language Processing makes it possible to instantly extract, map, and apply FDA and ISO requirements across your product development process.
Learn how Lexim transforms static guidance into real-time regulatory intelligence.
Pat Bhatt
Sep 174 min read


Can AI Predict FDA Feedback Before You Submit?
The regulatory path is full of unknowns—but it doesn’t have to be. Discover how LLMs can help predict FDA feedback before you submit, saving time, cost, and rework.
Read how Lexim uses AI to turn regulatory uncertainty into strategic clarity.
Pat Bhatt
Sep 174 min read
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