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Greenlight Guru Medical Device Blog

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What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers...
Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered - Featured Image

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

There are plenty of new requirements to be aware of in both the EU Medical Device Regulation (EU MDR...
Engineering Change Order: The Role it Plays in the Change Management Process - Featured Image

Engineering Change Order: The Role it Plays in the Change Management Process

Change is just part of life for medical device companies. No device makes it to market without quite...
How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist) - Featured Image

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

So you need to make a change to your medical device, what now?
7 Documentation Musts for All Software Device Premarket Submissions - Featured Image

7 Documentation Musts for All Software Device Premarket Submissions

As the prevalence of software in medical devices and software as medical devices (SaMD) has increase...
Definitive Guide to Change Management for Medical Devices - Featured Image

Definitive Guide to Change Management for Medical Devices

In an industry that is ever-evolving, change is inevitable.
Change Management Process Explained in 6 Easy Steps (+ free template) - Featured Image

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

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℠ - Featured Image

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

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 - Featured Image

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

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 - Featured Image

Understanding Change Management and Change Control in the Medical Device Industry

Change is inevitable in the medical device industry. Innovative device companies are at the constant...
Document Control for Medical Device Companies: The Ultimate Guide - Featured Image

Document Control for Medical Device Companies: The Ultimate Guide

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 - Featured Image

How to Build a QMS for a Medical Device

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

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