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The AI Touch: Artificial Intelligence Could Boost Quality Systems, Cut FDA Inspections – But Is Industry Ready?

Executive Summary

As the medical device industry begins to push the boundaries of artificial intelligence – exploring ways to use advanced AI systems to review, sort and process big data to find quality systems or product problems that would simply take too long for human eyes to see – FDA is also looking at ways to use AI for its own advantage. "AI will reduce investigational time and increase FDA's speed in taking action on a problematic firm," one agency official says. Meanwhile, a new Artificial Intelligence Initiative has been launched by Xavier University to better determine how AI can be used in the quality and regulatory space. Also: J&J subsidiary Janssen explains how it uses AI for quality and regulatory applications, and an expert from Shire tells how top management can be convinced that using artificial intelligence can save their firms money.


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