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Biocompatibility Testing and Fraudulent Data in the Age of AI

By Michelle Lott

Fraudulent data is becoming more common by the submission. So much so that the FDA recently published a press release reminding medical device manufacturers to scrutinize Third-Party Generated Data.” Regulatory consultant, Michelle Lott, discusses the agency’s use of artificial intelligence to find unusual patterns in submitted data and how you might guard against using fraudulent 3rd-party data.

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