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The International Medical Device Regulators Forum will launch its medical device single audit program (MDSAP) pilot in January in the U.S., Canada, Australia and Brazil. Read More
Medtronic was slapped with a 15-citation warning letter following a preapproval inspection for its MiniMed 530G continuous glucose monitoring system. Read More
FDA investigators increasingly are shifting from “top down” inspections focused on policies to “bottom up” inspections that focus on raw data, an industry insider says. Read More