30 min listen
What Devicemakers Need to Know About Medical Device Reporting (MDR)
FromGlobal Medical Device Podcast powered by Greenlight Guru
What Devicemakers Need to Know About Medical Device Reporting (MDR)
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
32 minutes
Released:
Nov 7, 2019
Format:
Podcast episode
Description
Medical device reporting, or MDR: what is it? What isn’t it? Why is it important?
The FDA recently released a guidance on medical device reporting, and today we’re talking to Mike Drues, president of Vascular Sciences, about MDR and what it means to medical device companies.
Mike 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’s episode of the Global Medical Device podcast.
Some of the highlights of the show include:
● Why the 2016 FDA guidance on MDR is so important to post-market surveillance.
● What types of events are supposed to be reported, including tips on trying to find the relationship between a device and potential adverse effects.
● The relationship between complaints and MDRs: The MDR is a subset of complaints, but not all complaints will lead to MDRs.
● Mike’s thoughts on the timeliness of the reports when it comes to severity and frequency of the adverse events.
● Why the FDA is putting out this new guidance now, even though the process has been around for a long time.
● Who 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.
● How reprocessors fit into the reporting requirements.
● Mike’s thoughts on why medical device reporting might eventually become a moot point.
The FDA recently released a guidance on medical device reporting, and today we’re talking to Mike Drues, president of Vascular Sciences, about MDR and what it means to medical device companies.
Mike 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’s episode of the Global Medical Device podcast.
Some of the highlights of the show include:
● Why the 2016 FDA guidance on MDR is so important to post-market surveillance.
● What types of events are supposed to be reported, including tips on trying to find the relationship between a device and potential adverse effects.
● The relationship between complaints and MDRs: The MDR is a subset of complaints, but not all complaints will lead to MDRs.
● Mike’s thoughts on the timeliness of the reports when it comes to severity and frequency of the adverse events.
● Why the FDA is putting out this new guidance now, even though the process has been around for a long time.
● Who 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.
● How reprocessors fit into the reporting requirements.
● Mike’s thoughts on why medical device reporting might eventually become a moot point.
Released:
Nov 7, 2019
Format:
Podcast episode
Titles in the series (100)
Tips to Help You Prepare for an FDA Inspection: On today’s episode, we’re introducing the newest addition to the greenlight.guru team, Jessica Lyons. Jessica is a 2007 graduate of Rose-Hulman Institute of Technology and has worked in the medical device product development for nearly 10 years. She ... by Global Medical Device Podcast powered by Greenlight Guru