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

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

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 - Featured Image

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

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 - Featured Image

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

While the current health crisis has served as a catalyst for innovation for medical device companies...
Meet a Guru: Erica Loring - Featured Image

Meet a Guru: Erica Loring

What makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with decad...
Case Study: How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With MDQMS - Featured Image

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

As medical device companies around the globe are continuing to operate among the implications of COV...
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference? - Featured Image

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

The medical device industry has a lot of acronyms. 
4 Emerging Trends in 2020 Backed by Medical Device Industry Experts - Featured Image

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

Throughout 2020, the medical device industry will see significant changes take flight. Among the big...
Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions - Featured Image

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

How a company chooses to establish and maintain their quality system has everything to do with their...
15 Questions to Ask QMS Software Vendors in the Medical Device Industry - Featured Image

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

As a medical device company, you are expected to deliver innovative, life-changing medical device(s)...
C2DX, Inc. Impresses auditors and Breezes through MDSAP AUDIT After Implementing Medical Device QMS (MDQMS) - Featured Image

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

  Experienced medical device professionals can agree that investing in quality early on and putting ...
Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market - Featured Image

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

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

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

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

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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