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

By The RND Group on July 26, 2020

The FDA has released a discussion guideline and request for feedback regarding changes in the certif...

By The RND Group on June 21, 2020

Do you remember what computing tools you were using in 2002? I would guess, if you were old enough t...

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 Nick Tippmann on April 22, 2020

What impact will the EU MDR changes have on the medical device ecosystem?

By Nick Tippmann on April 15, 2020

Why is verification and validation (V&V) confusing and challenging for many medical device profe...

By The RND Group on April 12, 2020

The ultimate goal of developing a medical device is to receive FDA approval and to be able to releas...

By Jon Speer on December 2, 2018

What you’ve known and believed about computer system validation, software validation, and 21 CFR Par...

By Kyle Rose on March 19, 2018

As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to t...

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