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Greenlight Guru Announces Enhanced Change Management Capabilities - Featured Image

Greenlight Guru Announces Enhanced Change Management Capabilities

By Nick Tippmann on December 9, 2019
Medical device quality management system (MDQMS) improves traceability and efficiency associated wit...
How to Solve the Medtech Value Equation with Quality Data - Featured Image

How to Solve the Medtech Value Equation with Quality Data

By Nick Tippmann on December 4, 2019
Which medical technology, product, or device are you actively focused on bringing to market that wil...
8 Most Common Mistakes to Avoid with FDA 21 CFR Part 820 - Featured Image

8 Most Common Mistakes to Avoid with FDA 21 CFR Part 820

By Jon Speer on November 27, 2019
If you’re a medical device company selling or planning to sell into the US market, you should be fam...
Why Supplier Quality Management Is So Important - Featured Image

Why Supplier Quality Management Is So Important

By Nick Tippmann on November 27, 2019
Effectively managing suppliers, vendors, consultants, and other third party entities that provide pr...
State of Medical Device Product Development and Quality Management Report 2020 - Featured Image

State of Medical Device Product Development and Quality Management Report 2020

By Jon Speer on November 25, 2019
Greenlight Guru, the only medical device quality management system (MD QMS) software platform, today...
FDA is Expanding its Case for Quality Program... Should Your Company Participate? - Featured Image

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

By Nick Tippmann on November 20, 2019
Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...
Definitive Guide to Change Management for Medical Devices - Featured Image

Definitive Guide to Change Management for Medical Devices

By Jon Speer on November 17, 2019
Preparing for EU MDR - Featured Image

Preparing for EU MDR

By Nick Tippmann on November 13, 2019
Do you have a regulatory strategy to help your company prepare for the new European Medical Device R...
Tips for Success with IEC 60601 for Electrical Medical Devices - Featured Image

Tips for Success with IEC 60601 for Electrical Medical Devices

By Wade Schroeder on November 10, 2019
Does your company develop electrical medical devices? The standard IEC 60601 is different from other...
Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction - Featured Image

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

By Nick Tippmann on November 6, 2019
Quality Assurance and Regulatory Affairs (QA/RA) professionals need to keep their finger on the puls...
EU MDR Implementation Guide - Featured Image

EU MDR Implementation Guide

By Michael Galliker on November 5, 2019
The European medical device industry will undergo significant changes as a result of the new medical...
How FDA Distinguishes Between Clearance vs. Approval vs. Granted - Featured Image

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

By Tom Rish on November 3, 2019
As a medical device professional, you are well aware of how much time and effort goes into getting y...

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