What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory strategies and pathways?
In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about the importance of and reasons for regulatory due diligence that all medical device professionals should know.
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Humanitarian Device Exemption (HDE)
FDA: Medical Device Guidance Documents
MedTech True Quality Stories Podcast
Greenlight Guru YouTube Channel
“Due diligence is knowing the state of affairs...from a regulatory perspective, before I dive too deep and invest too much time, money, effort, and resources.” Jon Speer
“Regulatory due diligence...is important for any medical device-whether it’s an existing device that’s similar to something already...or a new or novel device.” Mike Drues
“As a med device company, I have an obligation to make sure that the information about my product is...up to date and current.” Jon Speer
“As an industry, we tend to focus on the past, rather than the future...that’s kind of problematic.” Mike Drues
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...