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

Case Study: Centese ditches paper-based QMS AND achieves FDA 510(k) clearance

By Nick Tippmann on March 29, 2019

For many early-stage medical device companies, the default option when implementing a quality manage...

Case Study: How Innovere Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device eQMS

By Nick Tippmann on March 28, 2019

Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare...

Why Document Control Matters To Medical Device Companies

By Jon Speer on March 24, 2019

As medical device professionals, we share a common goal of producing safe and effective medical devi...

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

By Nick Tippmann on March 13, 2019

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...

Case Study: How Greenlight Guru is laying the foundation for success at Amnion Life

By Nick Tippmann on March 12, 2019

The majority of medical device companies operate on an emphasis of high quality outcomes and scalabi...

Quality, Fast, Cheap...Pick Two

By Mark D Proulx, CQA, cSSBB on February 24, 2019

You may think you're saving the company money by using that "free" Excel spreadsheet to track design...

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...

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...

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