Medical Device Quality, Regulatory and Product Development Blog

De Novo Pathway: Explaining the Process for Medical Device Companies

By Jon Speer on April 14, 2019

The De Novo pathway has been around for more than two decades, but it is still one of the least used...

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

By Nick Tippmann on April 11, 2019

It seems like every time you turn on the TV, there’s commercials, movies, and shows that highlight t...

Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories

By Jon Speer on April 7, 2019

I'm thrilled to announce the officially launch of Greenlight Guru's second podcast series, MedTech...

How Sonavex Went from Concept to FDA Clearance in Just 3 Years

By Nick Tippmann on April 7, 2019

How do medical device companies approach the “scaries” related to quality and guidance regulations w...

Improving the Quality of Life in the Most Delicate Patient Group: Preterm Born Infants

By Nick Tippmann on April 7, 2019

Premature birth is the #1 cause of infant mortality in the United States. Improving the quality of l...

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

By Edwin Bills, ASQ Fellow, RAC on April 1, 2019

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i] As ...

Case Study: Centese ditches paper-based QMS AND achieves FDA 510(k) clearance

By Nick Tippmann on March 29, 2019

For many early-stage medical device companies, the default option when implementing a quality manage...

Case Study: How Innovere Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device eQMS

By Nick Tippmann on March 28, 2019

Advanced magnetic resonance imaging (MRI) technology has become an important piece of healthcare...

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

By Nick Tippmann on March 27, 2019

FDA recently released a new guidance document titled, Safety and Performance Based Pathway, which pe...

Why Document Control Matters To Medical Device Companies

By Jon Speer on March 24, 2019

As medical device professionals, we share a common goal of producing safe and effective medical devi...

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

By Jon Speer on March 17, 2019

A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...

The Greenlight Guru True Quality Roadshow: Atlanta Recap

By Nick Tippmann on March 15, 2019

We’re back from the peach state and an evening at The Gathering Spot in Atlanta for The Greenlight G...

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