If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How do you navigate, capture, and document when and what to do?
In this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss FDA’s two, new guidance documents that provide additional transparency, consistency, and objectivity regarding benefit-risk determinations.
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FDA Breakthrough Devices Program (BDP)
Understanding ISO 14971 Medical Device Risk Management
Using the Bucket Method for Medical Device Risk Management
MedTech True Quality Stories Podcast
Greenlight Guru True Quality Roadshow
“Risk or uncertainty...has always been included in all product reviews of medical devices.”
“We’re creating yet another scale, another metric when we talk about uncertainty or risk. Risk is a complicated topic. It seems like we’re making it even more complicated.”
“They want to have a flexible and tailored approach in reviewing each device by itself ...and considering the totality of the evidence.”
“I am not a fan of the cookie-cutter approach to medical device development. Every medical device...should be considered on its own merits.”
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...