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eBooks and Guides

The Essential Guide to Preparing Your QMS for EU MDR

This is the essential guide to help you prepare your Quality Management System (QMS) for the new EU MDR before the transition period ends on May 26, 2020.

ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices

ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices offers industry professionals everything related to the topic. Greenlight Guru eQMS platform automates regulatory compliance with ISO 13485:2016, FDA, ISO 14971, so companies can focus on true quality of devices.

15 Reasons Medical Device Companies Choose Greenlight Guru

This eBook provides 15 reasons you need a solution such as Greenlight Guru that provides built-in compliance, provides traceability, takes little time to implement, and is augmented by experts with more than a decade in the medical device industry.

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Breakthrough Designation Program: Is This An Option For My Medical Device?

Quality Leaders' Playbook for Driving Executive Engagement with Quality Systems

Why Design Validation is More than Testing: How do we validate our validation?

In this free webinar participants will learn best practices for design validation, including how to avoid timely and costly validation mistakes and creative ways to use validation to their advantage!

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Global Medical Device Podcast

How General Wellness Devices Have Opened a Pandora's Box of Confusion

Episode 113

Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

Episode 112

Importance of Software Requirements in Product Development

Episode 111

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MedTech True Quality Stories Podcast

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

Becky Fitzgerald

Principal/Co-founder, Two Harbors Consulting

Eliminating Subjectivity And Guesswork With A Modernized Solution To Detecting Ear Infections

Ryan Shelton

Founder / CEO, PhotoniCare

Creating a Culture of Quality for Medical Device Companies

Devon Campbell

Founder, Prodct LLC

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Case Studies

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."

Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process with Greenlight Guru

"I highly recommend Greenlight Guru. They have taken a complex industry and made it into a product that’s simple to use.”

How Greenlight Guru is Laying the Foundation for Success at Amnion Life

“Greenlight Guru was essential for us to establish a strong foundation for success.”

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In The News
Not All Medical Device QMS Solutions Are Created Equal

Not All Medical Device QMS Solutions Are Created Equal

By Evan Luxon, Centese (Greenlight Guru customer), Medical Product Outsourcing, June 24th, 2019.

As an early-stage medical device company, it may seem simpler to implement a paper-based QMS than to choose from the thousands of QMS software providers out there. Better yet, you're saving money by choosing the paper-based route, right? Wrong.

Quality Is The Heartbeat Of Your Company

Quality Is The Heartbeat Of Your Company

By David Deram, Forbes, June 13th, 2019.

Quality is manifested by the level of commitment that’s invested. Quality outcomes don’t happen by chance; they are carefully crafted to deliver a memorable experience to the end user. This mindset is at the core of Greenlight Guru and serves as the heartbeat of the company.

Qualifying Your Suppliers Using a Risk-Based Approach

Qualifying Your Suppliers Using a Risk-Based Approach

By Jon Speer

Quality Digest, June 13th, 2019

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