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

Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events

By Nick Tippmann on October 19, 2020

New capability automates the quality event process through customized templates that increase effici...

3 Reasons Why Closed-Loop Traceability is a QMS Must

By Jon Speer on September 27, 2020

There is a growing expectation in the medical device industry of manufacturers to demonstrate closed...

Introducing Greenlight Guru Visualize: Quality at a Bird’s Eye View

By Nick Tippmann on September 20, 2020

Most people are visual learners. In fact, it has been reported that visuals can improve learning by ...

What are the Audit Etiquette Rules I Should be Following?

By Nick Tippmann on August 12, 2020

Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself acco...

How Do I Determine if my Product is a Medical Device?

By Jon Speer on August 2, 2020

Let’s say you’re in the medical industry but not yet in the medical device industry. You’re working ...

Meet a Guru: Jesseca Lyons

By Nick Tippmann on July 15, 2020

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with...

How to Escape the Lure of Legacy Quality Management Systems

By Jon Speer on July 12, 2020

Many device professionals in small to medium-sized businesses (SMB) still use legacy systems to supp...

Meet a Guru: Taylor Brown

By Nick Tippmann on July 1, 2020

What makes Greenlight Guru unique? The Guru Edge⁠—a team of medical device professionals with over e...

How to Validate Cloud-based Software Tools

By The RND Group on June 21, 2020

Do you remember what computing tools you were using in 2002? I would guess, if you were old enough t...

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...

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

By Jesseca Lyons on May 29, 2020

The medical device industry has a lot of acronyms.

22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles

By Jon Speer on May 24, 2020

The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device qua...

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