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In August 2015 the FDA’s Center for Devices and Radiological Health (CDRH) implemented a requirement for manufacturers and importers of medical devices to transition away from paper reporting, and to instead submit adverse event reports electronically. The electronic transmission of adverse event reports coupled with the mandatory reporting deadlines will allow the FDA to respond more readily to adulterated, misbranded or unsafe devices. Pilgrim Quality Solutions, created the eBook below to help manufacturers and importers transition to electronic medical device reporting.
Check out the eMDR e-book! 7 Tips for Transitioning to Electronic Medical Device Reporting
For more medical device strategies, join Pilgrim Quality Solutions at the American Medical Device Summit taking place on October 5-6 in Chicago, IL.
