Greenlight Guru's State of Medical Device Product Development and Quality Management 2020 Report is here.

Greenlight Guru Medical Device Blog

GET THE LATEST UPDATES FROM OUR BLOG:

Join 68,000+ other medical device professionals outperforming their peers.

Nick Tippmann

Nick Tippmann
Nick is the VP of Marketing at Greenlight Guru, the only quality management software platform designed specifically for medical device companies.

Author's Posts

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...
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...
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 AMNION LIFE IS LAYING THE FOUNDATION FOR SUCCESS WITH GREENLIGHT GURU - Featured Image

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

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 - 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...
How and When to Consider Human Factors - Featured Image

How and When to Consider Human Factors

When should you begin to consider human factors with your medical device design and development effo...
Who Should Own Your QMS? - Featured Image

Who Should Own Your QMS?

Does your medical device company prefer to outsource the responsibility of its quality management sy...
Design Validation vs. Human Factors Validation - Featured Image

Design Validation vs. Human Factors Validation

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

The Greenlight Guru Medical Device Blog

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

Our Most Popular Posts

Topics

See More Topics...