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

Introducing The Greenlight Guru True Quality Roadshow 2019

By Jon Speer on January 29, 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

By Jon Speer on January 7, 2019

Does your medical device company use a third-party or contract manufacturer?

Top 20 Medical Device Venture Capital Firms

By Nick Tippmann on November 18, 2018

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

By Jon Speer on November 11, 2018

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

By Jon Speer on October 14, 2018

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

By Nick Tippmann on October 10, 2018

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)

By Jon Speer on October 7, 2018

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?

By Jon Speer on August 26, 2018

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

By Jon Speer on August 19, 2018

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+)

By Nick Tippmann on January 12, 2018

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

By Jon Speer on December 18, 2017

Does your company have approval for IEC 60601-1? If you produce medical electrical equipment (MEE)...

What is CAPA in the Medical Device Industry?

By Jon Speer on February 6, 2017

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

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