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eBooks and Guides

Best QMS Software: Ultimate Guide To Comparing Quality Management System Solutions

The best QMS software comparison guide for medical device companies that will help you choose a quality management system solution that strategically benefits your product and company.

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

Know what questions to ask software vendors that give your medical device company the necessary information to consider when selecting a QMS software solution.

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.

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How to Implement and Maintain a Modern CAPA System while Avoiding Common

A free, in-depth webinar covering proven methods to improve your CAPA processes and tactical approaches you can start taking today to ensure the medical devices you design, develop, manufacture and market are safe and effective.

Insider’s look at the IEC 60601 Amendments: Detailed Guidance from Committee Member Responsible for Changes

A free, in-depth webinar covering the significant changes of the IEC 60601 Amendments and how medical device manufacturers and consultants can prepare accordingly.

Verification & Testing Strategies for Compliance with ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1

A free in-depth webinar covering the most effective verification and testing strategies companies can implement for compliance with ISO 13485:2016, IEC 62034 / 60601-1 / 82304-1.
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Global Medical Device Podcast

Challenges related to Home Use Devices

Episode 163

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

Episode 162

How Jon Speer Met His Most Frequent Guest: Mike Drues

Episode 161

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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

C2DX, INC. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)

"We wanted a QMS solution that was robust enough to grow with us, but simple enough to get us started."

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."

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In The News
Adopting a Data-Driven Approach to Quality with an MDQMS

Adopting a Data-Driven Approach to Quality with an MDQMS

By Jon Speer

Medical Product Outsourcing, September 24th, 2020

The Importance of Managing and Controlling Risk in the Medical Device Industry

The Importance of Managing and Controlling Risk in the Medical Device Industry

By Jon Speer

Quality Digest, September 8th, 2020

Areas to Consider in Medical Device Risk Management

Areas to Consider in Medical Device Risk Management

By Jon Speer

Medical Product Outsourcing, August 24th, 2020

View All Articles