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

By Jon Speer on June 23, 2019

Medical device companies selling or planning to sell into the US market should be familiar with FDA'...

By Jon Speer on April 30, 2018

If you’re a medical device company manufacturing Class II or Class III devices, you can expect to ha...

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 9, 2017

So, you have a certificate hanging on your wall showing that you’ve passed an audit and conform with...

By Jon Speer on October 1, 2017

What exactly is a risk-based QMS?

By Jon Speer on April 4, 2017

Over years of working with medical device companies, we’ve found that there is a particular area tha...

By Jon Speer on February 11, 2017

The goal for most creators of new medical devices is to be able to get them to market as quickly as ...

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