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...

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

By Sara Adams on August 29, 2021

At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality m...

Understanding the Value of a Medical Device Guru

By Nick Tippmann on May 26, 2021

Have you ever wondered, what does a medical device guru actually do? What role do they play within G...

What is a Quality Agreement for Medical Devices?

By Taylor Brown on April 11, 2021

There’s a good chance you’re not manufacturing your own medical device—contract medical device manuf...

Quality Management for IVD Devices vs Medical Devices

By Nick Tippmann on April 5, 2021

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD...

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...

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

By Jon Speer on February 16, 2021

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

By Nick Tippmann on February 15, 2021

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

How to Create a Quality Management Plan

By Sara Adams on February 9, 2021

Technically speaking, you can launch a product without a quality management plan—but most of your go...

5 Key Principles of Total Quality Management

By Taylor Brown on January 31, 2021

It's easy to think of quality as a niche responsibility, requiring only the involvement of those wor...

How Does a Medical Device Quality Management System Differ from other QMS Tools?

By Jon Speer on January 26, 2021

Establishing a more efficient and effective quality management system (QMS) has been a recurring que...

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