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5 top stories that mattered for medtech in 2018

January 14, 2019 By Chris Newmarker Leave a Comment

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 […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Apple, artificial intelligence, eMDR, FDA, opioid crisis

FDA reschedules eMDR system update

March 30, 2018 By Danielle Kirsh Leave a Comment

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 […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: eMDR

Upcoming changes to FDA electronic medical device reporting in 2018

December 22, 2017 By Danielle Kirsh Leave a Comment

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 […]

Filed Under: Blog, Food & Drug Administration (FDA) Tagged With: eMDR

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