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

Why a Visual QMS is So Important for Your Medical Device Company

By Jon Speer on February 16, 2021

How valuable would it be to have a visual representation of your entire QMS and all of its functioni...

How Does a Medical Device Quality Management System Differ from other QMS Tools?

By Jon Speer on January 26, 2021

Establishing a more efficient and effective quality management system (QMS) has been a recurring que...

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

By Jon Speer on January 10, 2021

So you need to make a change to your medical device, what now?

Understanding Change Management and Change Control in the Medical Device Industry

By Taylor Brown on January 4, 2021

Change is inevitable in the medical device industry. Innovative device companies are at the constant...

6 Benefits of the Best 21 CFR Part 11 Compliant Software

By Jon Speer on December 13, 2020

Nearly every medical device company is subject to software validation requirements, regardless of wh...

How to Write a Nonconformance Report

By Barret Mueller on October 4, 2020

Nonconformance is a word no quality manager wants to hear.

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...

Greenlight Guru Launches Visualize to Redefine the Medical Device Industry’s Approach to Closed-Loop Traceability

By Nick Tippmann on September 21, 2020

New machine learning powered capabilities provide device makers with instant visibility into the con...

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 ...

519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement

By Jon Speer on August 30, 2020

In the medical device industry, there’s a lot outside of our control. The market shifts. New, innova...

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 ...

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...

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