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

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

By Jon Speer on September 13, 2021

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

7 Documentation Musts for All Software Device Premarket Submissions

By Wade Schroeder on August 8, 2021

As the prevalence of software in medical devices and software as medical devices (SaMD) has increase...

Definitive Guide to Change Management for Medical Devices

By Jon Speer on January 22, 2021

In an industry that is ever-evolving, change is inevitable.

Change Management Process Explained in 6 Easy Steps (+ free template)

By Sara Adams on January 19, 2021

In Prosci’s research, participants were six times more likely to meet project goals by following an ...

Say Hello to Predictive Quality: Greenlight Guru Introduces Intelligent Document Management powered by Halo℠

By Nick Tippmann on January 18, 2021

Today’s medical device companies are moving, changing, and adapting at an incredibly rapid pace.

Greenlight Guru Launches Halo℠ For Change Management, World’s First AI & ML Recommendation Engine for Medical Device Quality

By Nick Tippmann on January 18, 2021

New predictive recommendation engine transforms the way medical device companies are able to discove...

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...

Document Control for Medical Device Companies: The Ultimate Guide

By Jon Speer on August 23, 2020

According to the original data findings of our 2020 State of Medical Device Product Development and ...

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...

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