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

How does EU MDR impact your Quality Management System?

By Nick Tippmann on February 22, 2021

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challe...

Greenlight Guru Announces True Quality Summit Series: EU MDR & IVDR

By Nick Tippmann on February 8, 2021

Leading MDQMS provider combines global regulatory leadership with original research data to provide ...

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

By Nick Tippmann on December 16, 2020

The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficu...

5 Tips for Medical Device Registration across Global Markets

By Jon Speer on August 9, 2020

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

Top 100 Medical Device Acronyms & Terminology You Need to Know

By Jon Speer on July 19, 2020

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

What are the Changes to ISO 14971:2019 & TR 24971?

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...

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

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...

5 Steps for Getting your CE Marking with EU MDR Requirements

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...

EU MDR: Not All Doom and Gloom

By Nick Tippmann on May 22, 2019

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

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

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The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i] As ...

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

By Rod Beuzeval on January 17, 2019

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

EU MDR and IVDR Are Live – Here Are Some Important Items You Should Know!

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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