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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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How To Apply Risk Management Throughout The Product Lifecycle Of Your Medical Device

In this free webinar participants will learn how to apply Risk Management (Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation, Production and Post Production Monitoring) to a medical device as it moves throughout the stages of the Product Lifecycle (Concept, Development, Launch, Post Market, Obsolescence).

10 Steps To Preparing Your 510(k) Submission (And How To Avoid The Common Pitfalls)

In this free webinar participants will learn about the key steps to take when preparing a 510(k) Premarket Notification and how to avoid common pitfalls that can occur during this process.

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

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Global Medical Device Podcast

Implementing Changes to SaMD under New EU MDR

Episode 118

Career Tips for QA/RA Professionals in the Medical Device Industry

Episode 117

Right-sizing your QMS

Episode 116

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MedTech True Quality Stories Podcast

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

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

Ryan Shelton

Founder / CEO, PhotoniCare

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Case Studies

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."

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.”

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In The News
The Essential Guide To Preparing Your QMS For EU MDR

The Essential Guide To Preparing Your QMS For EU MDR

By Jon Speer

The MedTech Conference , August 26th, 2019

How prepared is your quality management system for the new requirements of EU MDR for medical devices that will go into effect in less than a year? Learn what you need to do to prepare with this comprehensive guide.

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.

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