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3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US - Featured Image

3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US

Anyone who works in the medical device industry will tell you that quality and patient care is of th...
Top 3 Reasons for FDA 483 Observations in 2020 - Featured Image

Top 3 Reasons for FDA 483 Observations in 2020

The US Food and Drug Administration (FDA) has released the quality system inspection data for citati...
3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers - Featured Image

3 QMS Principles for Software As a Medical Device (SaMD) Manufacturers

Software as a Medical Device (SaMD) is a rapidly growing subset of the medical device industry, and ...
5 Biggest Quality Mistakes (And How You Can Avoid Making Them) - Featured Image

5 Biggest Quality Mistakes (And How You Can Avoid Making Them)

At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality m...
5 Postmarket Surveillance System Musts for Every EU Manufacturer - Featured Image

5 Postmarket Surveillance System Musts for Every EU Manufacturer

Designing, developing, and getting your medical device approved and onto the market is a huge accomp...
3 Things Med Device Startups Must Do When Implementing a QMS - Featured Image

3 Things Med Device Startups Must Do When Implementing a QMS

I often hear early-stage medical device companies say they’re not ready for a quality management sys...
First-In-Class Diagnostics Tool Gets 510(k) Clearance Thanks to Medical Device Success Platform - Featured Image

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

Meet a Guru: Etienne Nichols - Featured Image

Meet a Guru: Etienne Nichols

The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companie...
Meet a Guru: Laura Court - Featured Image

Meet a Guru: Laura Court

What makes Greenlight Guru unique? It’s the Guru edge⁠—a team of medical device professionals with a...
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...
Why a Visual QMS is So Important for Your Medical Device Company - Featured Image

Why a Visual QMS is So Important for Your Medical Device Company

How valuable would it be to have a visual representation of your entire QMS and all of its functioni...
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...

The Greenlight Guru Medical Device Blog

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

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