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eBooks and Guides

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.

21 CFR Part 11: A Complete Guide

We'll take you through each section of 21 CFR Part 11, FDA's regulation for electronic documentation and electronic signatures. We'll explain what the requirements actually mean and expound the most important points for you to know as a medical device company.

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Webinars

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!

Understanding Post-market Surveillance under EU MDR: Being Proactive, Not Reactive

A free webinar on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) that goes into effect May 2020, and how manufacturers can take a proactive role in their approach.

Why User Needs Matter & Their Benefits in Streamlining Device Design and Development

A free webinar about connecting empathy and purpose to gain meaningful user insights that translate into optimal design inputs and product quality in medical device development.

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Global Medical Device Podcast

Is Your Medical Device Company CAPA Happy?

Episode 106

Integrating Human Factors into Design Controls to Improve Patient Outcomes

Episode 105

Greenlight Guru In the Classroom: A University's Real-world Approach

Episode 104

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MedTech True Quality Stories Podcast

Advancing MRI Technology As We Know It Today

Schelte Post

Project Manager, MR Coils

How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran

Daniel Powell

CEO, Spark Biomedical

Improving the Quality of Life in the Most Delicate Patient Group: Preterm Infants

Amir Fassihi, M.D.

Founder and CEO, Amnion Life

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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
Qualifying Your Suppliers Using a Risk-Based Approach

Qualifying Your Suppliers Using a Risk-Based Approach

By Jon Speer

Quality Digest, June 13th, 2019

Choosing The Right QMS For Your Medical Device Company

Choosing The Right QMS For Your Medical Device Company

By Evan Luxon, Centese (Greenlight Guru customer)

MedTech Intelligence, May 14th, 2019

The Most Common Problems With Your CAPA Process

The Most Common Problems With Your CAPA Process

By Jon Speer

ECN, March 25th, 2019

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