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

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...

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...

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...

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

By Nick Tippmann on March 13, 2019

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...

Case Study: How AMNION LIFE IS LAYING THE FOUNDATION FOR SUCCESS WITH GREENLIGHT GURU

By Nick Tippmann on March 12, 2019

The majority of medical device companies operate on an emphasis of high quality outcomes and scalabi...

Nonbinding Feedback is a New Guidance You Should Know About

By Nick Tippmann on March 8, 2019

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

By Nick Tippmann on March 5, 2019

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

How and When to Consider Human Factors

By Nick Tippmann on February 28, 2019

When should you begin to consider human factors with your medical device design and development effo...

Who Should Own Your QMS?

By Nick Tippmann on February 21, 2019

Does your medical device company prefer to outsource the responsibility of its quality management sy...

Design Validation vs. Human Factors Validation

By Nick Tippmann on February 13, 2019

Human factors and risk create a lot of confusion in the medical device industry. What do you need ...

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