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eBooks and Guides

Definitive Guide to Change Management for Medical Devices

A definitive guide on change management best practices to help medical device companies understand and manage changes to documents, products, processes and more.

The Ultimate Guide To The EU MDR General Safety And Performance Requirements (GSPR)

In-depth guide covering the new EU MDR General Safety and Performance Requirements (GSPRs) that must be implemented under EU Medical Device Regulation (MDR 2017/745).

5 Do's And Don'ts When Choosing A Qms Solution For Your Medical Device Company

A guide to the top 5 recommended best practices that medical device companies should consider when choosing a quality management system (QMS) solution.

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Beyond Design Controls 101: Following the Regulation vs. Understanding its Intent

A free webinar covering the design control “framework” and recommendations to effectively meet their requirements. Emphasis will be placed not only on regulatory aspects but on effective design strategy, which is very important to avoid spending unnecessary time and money on an ineffective design control process.

Implementing Best Practice Medical Device Change Control Processes (While Avoiding Common Pitfalls)

A free webinar on how you can establish an effective medical device change control process to ensure internal consistency throughout your quality management systems and documentation.

An Exclusive Look at the New Changes to ISO 14971:2019 and ISO TR 24971:2019

A free webinar covering the new changes to ISO 14971:2019, the medical device risk management standard and its companion guidance document, ISO TR 24971:2019, that will be published by year-end.

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Global Medical Device Podcast

Navigating the Twists and Turns of Change Management for Medical Devices

Episode 130

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

Episode 129

5 Myths about QA/RA Recruiting in the Medical Device Industry

Episode 128

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MedTech True Quality Stories Podcast

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

Evan Luxon

Co-founder & CEO, Centese

Elevating True Quality with Software Medical Device for Early Cancer Detection and Treatment

Chad McClennan

President, CEO, Koios Medical,

Graham Anderson

CFO, Koios Medical,

Patricia Setti-Laperch

Director of Regulatory Compliance and Quality, Koios Medical

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

Becky Fitzgerald

Principal/Co-founder, Two Harbors Consulting

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Case Studies

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

“Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA submission.”

Centese Ditches Paper-based QMS and Achieves FDA 510(k) Clearance

"I have a high degree of confidence that as changes to the regulations occur, I won't have to worry about being out of compliance because we are using Greenlight Guru."

How Innovere Has Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device Specific eQMS

"With Greenlight Guru, you've got software, but also what amounts to a personal consultant. Those connections are powerful."

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In The News
5 Tips To Raise Funding For Your Medical Device

5 Tips To Raise Funding For Your Medical Device

By Jon Speer

Medical Design & Outsourcing, January 16th, 2020

5 Tips to Raise Investor Interest and Fund Your Medical Device

5 Tips to Raise Investor Interest and Fund Your Medical Device

By Jon Speer

Medical Product Outsourcing, January 15th, 2020

4 Keys to Funding Your Medical Device

4 Keys to Funding Your Medical Device

By Jon Speer

MedTech Intelligence, December 27th, 2019

View All Articles