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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 Contract Manufacturers Shouldn't Own Your Quality System - Featured Image

Why Contract Manufacturers Shouldn't Own Your Quality System

Does your medical device company use a third-party or contract manufacturer?
Top 20 Medical Device Venture Capital Firms - Featured Image

Top 20 Medical Device Venture Capital Firms

If you have a great idea for a medical device or have already founded your own medical company, chan...
Ultimate Guide to ISO 13485 Quality Management System (QMS) for Medical Devices - Featured Image

Ultimate Guide to ISO 13485 Quality Management System (QMS) for Medical Devices

            TABLE OF CONTENTS What is ISO 13485 Evolution of a Quality Management System ISO 13485 C...
15 Reasons Why Medical Device Companies Choose Greenlight Guru - Featured Image

15 Reasons Why Medical Device Companies Choose Greenlight Guru

The medical device industry has been undergoing a major shift for the past 20 years, and now that sh...
Regulatory Tips & Strategies from a Former FDA Reviewer - Featured Image

Regulatory Tips & Strategies from a Former FDA Reviewer

What are some recent trends and observations in the medical device industry regarding regulatory aff...
FDA Aligning to ISO 13485:2016 (and Why It Matters) - Featured Image

FDA Aligning to ISO 13485:2016 (and Why It Matters)

Earlier this year, the FDA announced their intentions to change the US’s current medical device regu...
FDA Case for Quality Program: What, Why and How? - Featured Image

FDA Case for Quality Program: What, Why and How?

We recently launched a webinar series alongside the FDA, looking at its Case for Quality Program.
AI Explainability: What That Means and Why it Matters in Healthcare - Featured Image

AI Explainability: What That Means and Why it Matters in Healthcare

Is AI a topic we should be focused on in the medical device industry? Artificial Intelligence has ta...
Ultimate List of Medical Device Incubators and Accelerators (50+) - Featured Image

Ultimate List of Medical Device Incubators and Accelerators (50+)

Medical startups around the United States face many of the same challenges when it comes to achievin...
15 Steps to Getting Approval for IEC 60601-1 - Featured Image

15 Steps to Getting Approval for IEC 60601-1

  Does your company have approval for IEC 60601-1? If you produce medical electrical equipment (MEE)...
What is CAPA in the Medical Device Industry? - Featured Image

What is CAPA in the Medical Device Industry?

If you’re relatively new to the medical device development industry, you will have worked out fairly...

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

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