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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A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...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...
Case Study: Lucerno Dynamics Has Simplified the 13485:2016 Certification Process With Greenlight Guru - Featured Image

Case Study: Lucerno Dynamics Has Simplified the 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...
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...
Quality, Fast, Cheap...Pick Two - Featured Image

Quality, Fast, Cheap...Pick Two

You may think you're saving the company money by using that "free" Excel spreadsheet to track design...
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...
What to Expect During an FDA QSIT Inspection - Featured Image

What to Expect During an FDA QSIT Inspection

You arrive at work one morning and there are FDA inspectors sitting in your waiting area. If you are...
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 ...

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