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

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...

2021 State of Medical Device Quality Management and Product Development Benchmark Report

By Nick Tippmann on December 8, 2020

Findings of a 2021 industry benchmark survey reveal internal divides within organizations are making...

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