The medical device industry faced some major challenges over the past year, from increased media scrutiny to regulatory uncertainty in both the U.S. and E.U. It’s worth noting, though, that many things have been going right for medtech. More than half of the roughly 100 largest medical device companies in the world saw their stock […]
FDA reschedules eMDR system update
The FDA recently announced that the eMDR adverse event code update that was originally set to take place on April 6 has been rescheduled for July 5. The delay in update will give AS2 submitters more time to develop and validate changes to adverse event compliant handling system with the test eMDR system that was […]
Upcoming changes to FDA electronic medical device reporting in 2018
Registrar Corp. Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury. An adverse event is when a device has a malfunction that could cause death or serious injury. Importers report this information to the manufacturer. The FDA has announced […]
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