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

How to Build a QMS for a Medical Device

By Nick Tippmann on July 8, 2020

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...

The Beginner's Guide to Design Verification and Design Validation for Medical Devices

By Jesseca Lyons on June 12, 2020

When your medical device product development project gets to Design Verification and Design Validati...

Case Study: How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With MDQMS

By Nick Tippmann on June 11, 2020

As medical device companies around the globe are continuing to operate among the implications of COV...

Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities

By Nick Tippmann on March 9, 2020

Medical device quality management system (MDQMS) aligns with latest version of globally recognized r...

4 Major Reasons to Use Document Version Control Software for your Medical Device

By Taylor Brown on January 26, 2020

With the incredible volume of documentation required by the FDA and ISO, using a document control sy...

Navigating the Twists and Turns of Change Management for Medical Devices

By Nick Tippmann on December 28, 2019

Change is constant… Especially in the medical device industry. Medical device change management can ...

Greenlight Guru Announces Enhanced Change Management Capabilities

By Nick Tippmann on December 9, 2019

Medical device quality management system (MDQMS) improves traceability and efficiency associated wit...

Definitive Guide to Change Management for Medical Devices

By Jon Speer on November 17, 2019

Implementing Changes to SaMD under New EU MDR

By Nick Tippmann on September 4, 2019

Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the ne...

What Should Really Trigger a CAPA?

By Jon Speer on April 4, 2017

Over years of working with medical device companies, we’ve found that there is a particular area tha...

Understanding the New FDA Guidance on Changes to a 510(k)

By Nick Tippmann on October 26, 2016

What happens you need to make a change to a device that’s been cleared via 510(k)?

5 Places Paper Might Be Hiding in Your Medical Device Company

By Jesseca Lyons on July 11, 2016

A few weeks ago you left a big pile of paperwork (also known as your Document Change Order (DCO/ECO)...

Greenlight Guru Medical Device Blog