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eBooks and Guides

5 Do's And Don'ts When Choosing A Qms Solution For Your Medical Device Company

A guide to the top 5 recommended best practices that medical device companies should consider when choosing a quality management system (QMS) solution.

A Complete Guide to Bringing a Medical Device to Market

A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global markets.

Ultimate Guide To Agile Design And Development For Medical Devices

In-depth overview of Agile design and development processes to improve risk and quality management of medical devices that fulfill user and business needs.

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Post-market Surveillance For Medical Devices And Combination Products: If A Device Is Fda Cleared Or Approved, Can We Assume It’s Safe And Effective?

In this free webinar participants will learn post-market surveillance best practices
for medical devices and combination products to avoid timely and costly mistakes, as well as creative ways to use post-market surveillance to their advantage! 

How and When to Start Documenting your Formal Design Controls with DHF Ready Ideation

In this free webinar participants will learn how and when to start formal design controls to improve product development through an innovative and proven approach known as DHF Ready Ideation.

How And When To Register EU Medical Devices And Report UDI Information To EUDAMED

In this free webinar participants will learn how and when to register EU medical devices and report Unique Device Identification (UDI) information to EUDAMED, manage UDI submission data, and prepare for expected future challenges with UDI once EU MDR goes into effect.

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Global Medical Device Podcast

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

Episode 123

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

Episode 122

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

Episode 121

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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
Top 4 Mistakes When Implementing ISO 13485

Top 4 Mistakes When Implementing ISO 13485

By Jon Speer

Medical Design & Outsourcing, October 30th, 2019

Five Tips From Medtech Executives on the Value of Quality

Five Tips From Medtech Executives on the Value of Quality

By Jon Speer

Quality Digest, October 22nd, 2019

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.

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