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

Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance

By Etienne Nichols on May 5, 2022

A Performance Evaluation (PE) is required for any in vitro diagnostic device (IVD) that a manufactur...

Understanding Technical Documentation in EU Regulations

By Laura Court on March 13, 2022

Generally speaking, technical documentation is the compilation of documents that explains how a prod...

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

By Sara Adams on February 6, 2022

The European Union Medical Device Regulation (EU MDR) and European Union In Vitro Diagnostic Regulat...

Tips for Virtual Audits Your Medical Device Company Can Implement Today

By Sara Adams on December 7, 2021

Auditing medical device manufacturers is one of the most important aspects of ensuring quality stand...

Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered

By Etienne Nichols on December 5, 2021

There are plenty of new requirements to be aware of in both the EU Medical Device Regulation (EU MDR...

Preparing for EUDAMED - Europe’s Medical Device Database

By Taylor Brown on November 30, 2021

In 2017, the European Commission (EC) released two new regulations, one specific to medical devices ...

Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices

By Taylor Brown on November 23, 2021

In the European Union, in vitro diagnostic (IVD) devices are governed by a specific set of regulatio...

Explaining IVDR Classification for In Vitro Medical Devices

By Wade Schroeder on November 19, 2021

The In Vitro Diagnostic Regulation (IVDR), which concerns in vitro diagnostic medical devices in the...

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...

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