{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fac6bd817-a1b6-468a-8d76-d5e2fe8ae4c3","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"What Devicemakers Need to Know About Medical Device Reporting (MDR)","description":"Medical device reporting, or MDR: what is it? What isn\u2019t it? Why is it important? \n\nThe FDA recently released a guidance on medical device reporting, and today we\u2019re talking to Mike Drues, president of Vascular Sciences, about MDR and what it means to medical device companies. \n\nMike is a frequent guest on our show and really knows just about everything there is to know about medical device reporting. Sit back and enjoy today\u2019s episode of the Global Medical Device podcast.\n\nSome of the highlights of the show include:\n\n\u25cf\tWhy the 2016 FDA guidance on MDR is so important to post-market surveillance.\n\u25cf\tWhat types of events are supposed to be reported, including tips on trying to find the relationship between a device and potential adverse effects.\n\u25cf\tThe relationship between complaints and MDRs: The MDR is a subset of complaints, but not all complaints will lead to MDRs.\n\u25cf\tMike\u2019s thoughts on the timeliness of the reports when it comes to severity and frequency of the adverse events.\n\u25cf\tWhy the FDA is putting out this new guidance now, even though the process has been around for a long time.\n\u25cf\tWho counts as a manufacturer in terms of the FDA guidance. Mike answers whether dentists, hospitals and physicians must report problems according to the letter of the law vs. the spirit of the law.\n\u25cf\tHow reprocessors fit into the reporting requirements.\n\u25cf\tMike\u2019s thoughts on why medical device reporting might eventually become a moot point.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/c123b698-861d-418f-961d-cc98071fa842/8cc21f3e-e0c5-4c02-a0fc-1e9e8c015c77.jpg"}