Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

15 Reasons Why Medical Device Companies Choose Greenlight Guru

By Jon Speer on October 14, 2018

The medical device industry has been undergoing a major shift for the past 20 years, and now that sh...

Why Your Company Needs an Electronic Quality Management System

By Jon Speer on August 12, 2018

It’s time to face facts: a paper-based quality management system is no longer an option.

Why There is a Need for Multi-Level Design Controls

By Nick Tippmann on July 12, 2018

We’ve added an exciting new update to our platform recently. The ability to manage multi-level desig...

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years

By Connor Remaley on July 10, 2018

Have you ever wondered what partnering with Greenlight Guru could mean for your business? We have a ...

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

By Nick Tippmann on May 25, 2018

It can be challenging for small companies to navigate the medical device regulatory pathways, especi...

MYOLYN Gains 510(k) Clearance 48% Quicker Than Average Using Greenlight Guru

By Nick Tippmann on May 25, 2018

For any startup medical device company, the road to FDA 510(k) clearance can be fraught with any num...

Understanding the New Requirements for QMS Software Validation in ISO 13485:2016

By Kyle Rose on March 19, 2018

As I am sure many of you know, the ISO 13485 standard was updated in 2016, which means the time to t...

Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017

By Nick Tippmann on December 25, 2017

Thanks for helping make 2017 another big and exciting year for Greenlight Guru filled with tremendou...

What Does a Risk-Based QMS Mean?

By Jon Speer on October 1, 2017

What exactly is a risk-based QMS?

Key Challenges for Risk Management in Medical Device Development

By Jon Speer on January 29, 2017

If you’re in the business of developing medical devices, then risk and risk management become terms ...

Top 10 Most Popular Medical Device Articles of 2016 (Plus Top 5 Free Webinars and Podcasts) - Featured Image

Greenlight Guru Invited to Host Two Workshop Sessions at RAPS Convergence San Jose 2016

By Nick Tippmann on August 17, 2016

Be sure to come out and meet some of the Greenlight Guru team at the RAPS Convergence in San Jose Se...

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