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eBooks and Guides

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

In-depth guide covering the requirements of 21 CFR Part 820, FDA's quality system regulation for medical devices, including tips on how to comply and avoid common pitfalls.

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.

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Webinars

Change Management and Risk Management: How do we connect the dots and what happens if we don’t?

Free interactive webinar demonstrating how to integrate change management and risk management and will share best practices using case studies from a variety of clinical specialties.

When Do We Need FDA’s Permission to Market Our Device and When Do We Not?

A free, in-depth webinar exploring what is and is not a regulated medical device and how manufacturers can interpret and leverage FDA's definition of a device.

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.

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Global Medical Device Podcast

Visualizing a Medical Device through Illustrations, Animations, and other Artwork

Episode 184

Everything you Need to Know about SaMD from an FDA Perspective

Episode 183

Preparing for Remote and On-Site Inspections and Audits

Episode 182

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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

How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With MDQMS

"Showing traceability and documenting takes seconds in Greenlight Guru, compared to hours in a paper-based system."

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.”

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In The News
Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

By Nick Tippmann

Medical Product Outsourcing, December 4th, 2020

Imagine It’s 2030: What Was the Key To Business Success During COVID-19?

Imagine It’s 2030: What Was the Key To Business Success During COVID-19?

By David DeRam

Inside INdiana Business, December 3rd, 2020

Traceability Requirements in EU MDR

Traceability Requirements in EU MDR

By Jon Speer

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

View All Articles