Reminiscing about past and present lessons learned from listening to conversations with this show’s most frequent guest, one important principle emerged: Teach others how to think, not what to think.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues, president of the medical device consultancy firm, Vascular Sciences.
Anyone who’s listened to the show knows that Jon and Mike are passionate about the world of medical devices, particularly design controls, regulatory affairs, and prudent engineering practices. Listen to this episode where they revisit how they met in December 2014 and what they have shared and learned through the years.
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820.30 Design Controls - Code of Federal Regulations (CFR)
Design Control Guidance For Medical Device Manufacturers - FDA
Webinar: Why Design Validation is more than Testing: How do we validate our validation?
The Greenlight Guru True Quality Virtual Summit
Greenlight Guru YouTube Channel
MedTech True Quality Stories Podcast
“What I appreciate most about my relationship with Mike Drues is that he has caused me to think about the world a lot differently, specifically within the med device space.” Jon Speer
“We are passionate about medical device product development and design controls and prudent engineering.” Jon Speer
“Companies getting in trouble with the FDA is because they try to focus more on what the regulation says, as opposed to trying to understand and follow the intent of the regulation.” Mike Drues
“Design controls were very vague, and they were written purposely very vague because the medical device industry is a very broad industry.” Mike Drues
“I’m not saying, don’t follow the rules. I’m not advocating anarchy.” 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...