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

Case Study: How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile

By Nick Tippmann on September 28, 2021

“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical d...

Case Study: How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical

By Nick Tippmann on September 24, 2021

“Having partners with common values is just as important as the product or services themselves.” Dan...

First-In-Class Diagnostics Tool Gets 510(k) Clearance Thanks to Medical Device Success Platform

By Nick Tippmann on August 13, 2021

Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success

By Nick Tippmann on August 6, 2021

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

Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification

By Nick Tippmann on July 30, 2021

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

Centese Trades in Paper-based QMS for Medical Device Success Platform & Achieves 510(k) Clearance

By Nick Tippmann on June 22, 2021

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

How SOLIUS Replaced Paper with eQMS to Gain ISO 13485:2016 Certification in Weeks

By Nick Tippmann on May 4, 2021

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

Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

By Nick Tippmann on March 16, 2021

The IVD market reaches into all corners of the world, and for many device companies, this niche prod...

Case Study: How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a MDQMS

By Nick Tippmann on February 15, 2021

While the current health crisis has served as a catalyst for innovation for medical device companies...

Case Study: How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With MDQMS

By Nick Tippmann on June 11, 2020

As medical device companies around the globe are continuing to operate among the implications of COV...

C2DX, Inc. Impresses auditors and Breezes through MDSAP AUDIT After Implementing Medical Device QMS (MDQMS)

By Nick Tippmann on October 17, 2019

Experienced medical device professionals can agree that investing in quality early on and putting ...

Case Study: How AMNION LIFE IS LAYING THE FOUNDATION FOR SUCCESS WITH GREENLIGHT GURU

By Nick Tippmann on March 12, 2019

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

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