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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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Webinars

How to Integrate Risk Management throughout the Lifecycle of a Medical Device in the Coming Decade

A free webinar reviewing the application of a modern approach to risk management (risk analysis, risk evaluation, risk control, overall residual risk evaluation, production and postproduction monitoring) as a product moves through the product lifecycle (concept, development, launch, postmarket, obsolescence).

3 Ways Medical Device Companies Working Remote Are Leveraging QMS Software To Foster Innovation And Collaboration

This free in-depth webinar will cover how companies using turn-key, best-in-class QMS software are able to remain agile in order to innovate and outperform the competition.

How Can Medical Device Companies Use The Emergency Use Authorization (EUA) To Address The Covid-19 Pandemic?

This free in-depth webinar will explore the Emergency Use Authorization — specifically in the context of COVID-19 — and how medical device companies can use it.

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Global Medical Device Podcast

Meet a Guru: Taylor Brown

Episode 153

What is Regulatory Due Diligence for Medical Devices?

Episode 152

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

Episode 151

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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
Best Practices for Leading Medical Device Teams During the COVID-19 Pandemic

Best Practices for Leading Medical Device Teams During the COVID-19 Pandemic

By Jon Speer

MedTech Intelligence, June 24th, 2020

Managing and Leading Medical Device Companies and Teams During the Pandemic

Managing and Leading Medical Device Companies and Teams During the Pandemic

By Jon Speer

Medical Product Outsourcing, May 28th, 2020

COVID-19’s Impact on the MedTech Industry: How to Get Through

COVID-19’s Impact on the MedTech Industry: How to Get Through

By Jon Speer

MedTech Intelligence, May 19th, 2020

View All Articles