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What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

By Sara Adams on January 30, 2022
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

By Etienne Nichols on December 5, 2021
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

By Jesseca Lyons on November 21, 2021
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)

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 - Featured Image

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 - Featured Image

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) - Featured Image

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℠ - Featured Image

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 - Featured Image

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 - Featured Image

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 - Featured Image

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 - Featured Image

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...

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