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Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor - Featured Image

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

If you are in the business of medical devices, then you must eat, breathe, and live quality manageme...
Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey - Featured Image

Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

In episode #10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt...
How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans - Featured Image

How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

In episode #9 of the Global Medical Device Podcast we’re joined by Mike Cremeans. Mike is the Vice P...
How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues - Featured Image

How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues

In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascu...
Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson - Featured Image

Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

On today's episode of the Global Medical Device Podcast, we’re discussing how startup entrepreneurs ...
How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken - Featured Image

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

What are the most common mistakes a startup medical device company usually make? Hear Ronny Bracken ...
Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Companies - Featured Image

Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Companies

In today’s episode of the Global Medical Device Podcast Jon Speer welcomes Sara Naab to the show. Sa...
Risk Management from a Regulatory & Product Development Perspective [Podcast] - Featured Image

Risk Management from a Regulatory & Product Development Perspective [Podcast]

  Risk management for medical devices from a regulatory and product development perspective is the t...
How To Improve Your Design Reviews (Bonus Episode) - Featured Image

How To Improve Your Design Reviews (Bonus Episode)

Medical device design reviews - are more or less better? What about independent reviews? Are they ne...
How To Improve Your Medical Device Design Reviews - Featured Image

How To Improve Your Medical Device Design Reviews

"Medical device Design Reviews are critical steps within your design and development process.  They ...
Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation? - Featured Image

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

Superbugs.  Reprocessing. The White House. And Design Controls. Probably not a combo of topics you s...
[Podcast] Best Practices for Implementing Design Controls for the Medical Device Industry - Featured Image

[Podcast] Best Practices for Implementing Design Controls for the Medical Device Industry

If you're like many in the medical device industry, you've probably had some questions at one time o...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.