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

By Nick Tippmann on May 6, 2021

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many devic...

By Nick Tippmann on March 15, 2021

Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that h...

By Nick Tippmann on May 20, 2020

Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end u...

By Tommy Cooper on April 19, 2020

A common dilemma for early stage medical device companies is their lack of expertise in medical devi...

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 February 16, 2020

Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...

By Tom Rish on January 2, 2020

What I am about to share with you is a guide to medical device regulatory classification.

By John F. Johnson III on April 7, 2017

“This is a what” is not only a torturous summer-camp game, but an essential question when working to...

By Jon Speer on September 9, 2014

So you're developing a medical device? Congratulations!

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