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Top 50 Medical Device Product Design and Development Companies - Featured Image

Top 50 Medical Device Product Design and Development Companies

Medical device companies have to overcome many significant challenges when bringing a new product to...
Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm - Featured Image

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

Do you love quality and regulatory and keeping up with all things related to the medical device indu...
De Novo Pathway: Explaining the Process for Medical Device Companies - Featured Image

De Novo Pathway: Explaining the Process for Medical Device Companies

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 - Featured Image

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

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 - Featured Image

Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories

  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 - Featured Image

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

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 - Featured Image

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

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 - Featured Image

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...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

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

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 - Featured Image

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

    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 - Featured Image

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

FDA recently released a new guidance document titled, Safety and Performance Based Pathway, which pe...
Why Document Control Matters To Medical Device Companies - Featured Image

Why Document Control Matters To Medical Device Companies

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

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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