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

By Jon Speer on May 19, 2019

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

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 ...

By Jon Speer on October 1, 2017

What exactly is a risk-based QMS?

By Jon Speer on July 9, 2017

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

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...

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...

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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