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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 ...
5 Most Common Problems with your CAPA Process - Featured Image

5 Most Common Problems with your CAPA Process

Year after year, the corrective and preventive action (CAPA) process continues to be the most widely...
Medical Device Product Development Value Proposition - Featured Image

Medical Device Product Development Value Proposition

It doesn’t matter how long a company has been in business. Both startups and established companies n...
Top 35+ Medical Device Conferences To Attend in 2019 - Featured Image

Top 35+ Medical Device Conferences To Attend in 2019

Simply attending the right conferences can be a game-changer for those in the medical device industr...
Introducing The Greenlight Guru True Quality Roadshow 2019 - Featured Image

Introducing The Greenlight Guru True Quality Roadshow 2019

To the Medical Device Community, From the moment Greenlight Guru was founded, we have taken our lead...
Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies - Featured Image

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

Regulatory compliance is critically important. However, some think product liability is just as impo...
Best Practices for Effective Medical Device Design Reviews - Featured Image

Best Practices for Effective Medical Device Design Reviews

Design Reviews are intended to be checkpoints during medical device product development to ensure th...
Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016 - Featured Image

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

One thing that seems to be constant in the global medical device industry is change.

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