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eBooks and Guides

Ultimate Guide to Document Control

In-depth guide for medical device companies on how to control documents and improve procedures, with actionable solutions to common problems with document control activities and methods for implementing a document management system that enables product and business success.

Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices

Learn the most up to date recommendations and best practices from the ISO 14971:2019 standard and how you can start to use risk management as a tool - not a checkbox activity.

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.

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Webinars

3 Powerful Ways to Revolutionize Your Approach to Closed-Loop Quality System Traceability

A free, in-depth webinar covering the challenges medical device companies face today when demonstrating closed-loop traceability, the growing emphasis from industry standards and regulations, and the strategies, tactics, and tools device professionals can use to achieve truly connected quality.

Best Tools & Tricks for Meeting IVDR Requirements to Obtain CE Marking

A free, in-depth webinar covering the best tools and tricks for manufacturers of in vitro diagnostic devices to meet IVDR requirements and obtain CE Marking.

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.

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Global Medical Device Podcast

What Goes into Designing Devices for Military and Emergency Applications?

Episode 169

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

Episode 168

Positive and Negative Impacts of EUA on the Medical Device Industry

Episode 167

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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
Traceability Requirements in EU MDR

Traceability Requirements in EU MDR

By Jon Speer

Medical Device and Diagnostic Industry (MD+DI), November 12th, 2020

Four Essential Processes in Medical Device Risk Management

Four Essential Processes in Medical Device Risk Management

By Jon Speer

Quality Digest, September 29th, 2020

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

View All Articles