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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 Use UX to Streamline Medical Device Product Cycles

A free in-depth webinar outlining a process that not only fits within the regulatory parameters, but also is so effective that it shortens the typical product development cycle leading up to your regulatory submission.

Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices

A free in-depth webinar covering the most important items that companies must understand and put into practice when developing and commercializing SaMDs.

Behind the Stats: Medical Device Product Development & Quality Management Benchmark Survey

A free in-depth webinar on industry benchmark survey findings of over 500 medical device professionals around the globe, covering the most compelling stats, biggest surprises, and must-know takeaways device makers need to know.

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Global Medical Device Podcast

How to Integrate Usability into your Medical Device

Episode 139

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

Episode 138

How to Leverage IEC 62304 to Improve SaMD Development Processes

Episode 137

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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
Paper Processes: Three Reasons It’s a Costly Business Move

Paper Processes: Three Reasons It’s a Costly Business Move

By Jon Speer

MedTech Intelligence, March 6th, 2020

Paper Is Expensive

Paper Is Expensive

By Jon Speer

Quality Digest, February 17th, 2020

The True Cost of Paper

The True Cost of Paper

By Jon Speer

Medical Product Outsourcing, February 13th, 2020

View All Articles