Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

By Nick Tippmann on May 6, 2020

What does the 510(k) process involve? How should medical device companies know if this is the right ...

By Nick Tippmann on February 26, 2020

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...

By Tom Rish on November 3, 2019

As a medical device professional, you are well aware of how much time and effort goes into getting y...

By Nick Tippmann on May 9, 2019

Is de novo a realistic regulatory pathway? Or, the “kiss of death” for your product? No, to de novo?...

By Jon Speer on April 14, 2019

The De Novo pathway has been around for more than two decades, but it is still one of the least used...

By Jon Speer on April 23, 2018

Every medical device developer would like to take the fastest path to market, right?

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