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

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...

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

By Nick Tippmann on March 29, 2021

Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself?...

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...

Why Supplier Quality Management Is So Important

By Nick Tippmann on November 27, 2019

Effectively managing suppliers, vendors, consultants, and other third party entities that provide pr...

Qualifying Your Suppliers Using a Risk-based Approach

By Jon Speer on May 19, 2019

This notion of risk-based processes within quality systems is something that has become part of our ...

4 Tips for Handling Nonconformances

By Jon Speer on February 12, 2018

The safety and efficacy of your product rides heavily on the quality of the components that make it ...

What Does a Risk-Based QMS Mean?

By Jon Speer on October 1, 2017

What exactly is a risk-based QMS?

13 Common Pitfalls to Avoid During Medical Device Product Development

By Jon Speer on July 9, 2017

Are you falling into some of the common traps that surround medical device product development?

What is a “Quality Data Source” for your CAPA Process?

By Jon Speer on April 17, 2017

There’s a phrase that the FDA states in their policies around CAPA, which elicits a few questions. T...

Fundamentals of Supplier Management for Medical Device Companies

By Jesseca Lyons on March 19, 2017

As a manufacturer of medical devices, it is your responsibility to be on top of the entire system th...

4 Medical Device Quality System Musts for Startups

By Jon Speer on May 31, 2016

Medical device startups have a pile of things to address yet often don’t have the pile of money to t...

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