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What Device Makers Need to Know About Design Verification and Validation with Mike Drues - Featured Image

What Device Makers Need to Know About Design Verification and Validation with Mike Drues

Here’s a question for our listeners: When it comes to making sure your medical devices are safe and ...
The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important) - Featured Image

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

It’s time to break down the how and why of intended use and indications of use statements for your n...
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...
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...
Best Practices for Implementing Design Controls for the Medical Device Industry - Featured Image

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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