FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You? - a podcast by Greenlight Gurus Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers
from 2019-11-07T15:07:12
The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device Reporting (MDR).
On today’s episode, we have Mike Drues, president of Vascular Sciences, to help us dive into the impact of this proposal and the safety of medical devices.
The FDA proposal’s benefits probably outweigh the risks and should be implemented on a small scale.
Some highlights of the show include
●Depending on the severity of the malfunction, you are given a specified amount of time to report it.
●What companies should do to make patients and providers aware of issues.
●Should you react immediately or investigate the root cause? A malfunction is a serious matter and time is critical.
●The importance of having decision trees and processes in place before an issue arises.
●A company’s obligations for severe, life-threatening events and reporting timeframes.
●Rather than reporting individual malfunctions, companies will report malfunction summaries every quarter.
●Companies should be proactive and keep an eye on competitors’ similar products that have problems.
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Further podcasts by Greenlight Guru's Jon Speer + Medical Device Quality Regulatory Leaders, Entrepreneurs, Consultants, R&D Engineers