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

Assessing the Global Regulatory Landscape

By Nick Tippmann on October 20, 2021

With medical device regulations tightening around the world, especially in Europe, it's important to...

Choosing an EU Authorised Representative (EC REP) for Medical Device Regulatory Issues

By EMERGO by UL on October 15, 2021

So you're ready to export to Europe. You've tackled the myriad tasks associated with packaging, mark...

How to Make Your QMS Comply with EU MDR and IVDR

By Etienne Nichols on May 9, 2021

If your company has or is looking to place medical devices on the EU market, you need to know about ...

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

By Nick Tippmann on May 6, 2021

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

Greenlight Guru Named Premier QMS Software for NIH RADx Initiative

By Nick Tippmann on April 15, 2021

MDQMS leader to support national COVID-19 diagnostics program through purpose-built solutions.

Quality Management for IVD Devices vs Medical Devices

By Nick Tippmann on April 5, 2021

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD...

Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

By Nick Tippmann on March 16, 2021

The IVD market reaches into all corners of the world, and for many device companies, this niche prod...

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...

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