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

By Jon Speer on August 9, 2020

You have compiled all of the necessary documentation for your regulatory submission, submitted it to...

By Jon Speer on July 19, 2020

In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...

By Jon Speer on April 12, 2020

Proper risk management is a key process throughout the entire life cycle of a medical device. This i...

By Taylor Brown on February 9, 2020

As leaders of medical device companies, our goal is always to create devices that are safe and effec...

By Tom Rish on January 12, 2020

It has long been thought that the quickest path to market for medical device manufacturers is to acc...

By Nick Tippmann on May 22, 2019

Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MD...

By Edwin Bills, ASQ Fellow, RAC on April 1, 2019

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i] As ...

By Rod Beuzeval on January 17, 2019

One thing that seems to be constant in the global medical device industry is change.

By Dr. Gert W. Bos on May 16, 2017

After almost 10 years of careful deliberations, the new EU regulations on medical devices finally ha...

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