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4 Tips for Handling Nonconformances - Featured Image

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? - Featured Image

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 - Featured Image

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? - Featured Image

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 - Featured Image

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 - Featured Image

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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