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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...
5 Actionable Lessons Learned from the RADx Initiative by NIH - Featured Image

5 Actionable Lessons Learned from the RADx Initiative by NIH

By Nick Tippmann on January 27, 2021
Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Hea...
Understanding and Handling Different Types of Feedback - Featured Image

Understanding and Handling Different Types of Feedback

By Nick Tippmann on January 14, 2021
What’s the relationship between product feedback, complaints, and adverse events? 
6 Benefits of the Best 21 CFR Part 11 Compliant Software - Featured Image

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...
Why SaMD Companies Should be Leveraging Pre-Submissions to FDA - Featured Image

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

By Nick Tippmann on December 2, 2020
Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device ind...
3 Reasons Why Closed-Loop Traceability is a QMS Must - Featured Image

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...
Quality Assurance vs. Quality Control in the Medical Device Industry - Featured Image

Quality Assurance vs. Quality Control in the Medical Device Industry

By Jon Speer on September 6, 2020
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...
519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement - Featured Image

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...
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 ...
Unannounced Audits: A Survival Guide for Quality Managers - Featured Image

Unannounced Audits: A Survival Guide for Quality Managers

By Jon Speer on August 16, 2020
We’re in an industry that requires preparation. Unlike less regulated industries, there’s an expecta...
5 Tips for Medical Device Registration across Global Markets - Featured Image

5 Tips for Medical Device Registration across Global Markets

By Jon Speer on August 9, 2020
You have compiled all of the necessary documentation for your regulatory submission, submitted it to...
Meet a Guru: Tom Rish - Featured Image

Meet a Guru: Tom Rish

By Nick Tippmann on August 5, 2020
What makes Greenlight Guru so unique, beyond its medical device QMS (MDQMS) software? Its Guru edge.

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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