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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The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...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...
Abbreviated 510(k): Substantial Equivalence Through Performance Criteria - Featured Image

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...
The Greenlight Guru True Quality Roadshow: Atlanta Recap - Featured Image

The Greenlight Guru True Quality Roadshow: Atlanta Recap

We’re back from the peach state and an evening at The Gathering Spot in Atlanta for The Greenlight G...
Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process With Greenlight Guru - Featured Image

Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process With Greenlight Guru

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...
Case Study: How Greenlight Guru is laying the foundation for success at Amnion Life - Featured Image

Case Study: How Greenlight Guru is laying the foundation for success at Amnion Life

The majority of medical device companies operate on an emphasis of high quality outcomes and scalabi...
Why Flexible Design Reviews Matter for Medical Device Product Development - Featured Image

Why Flexible Design Reviews Matter for Medical Device Product Development

It is my humble and expert opinion that the medical device industry has the most significant impact ...
Nonbinding Feedback is a New Guidance You Should Know About - Featured Image

Nonbinding Feedback is a New Guidance You Should Know About

FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Ins...
Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams - Featured Image

Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams

Medical device quality management system debuts flexible design review capabilities for devices with...

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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