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

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...

5 Myths Engineers Believe About Quality (and what is really true)

By Jon Speer on November 4, 2018

A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...

How To Drive Executive Engagement With Quality Systems (and actually get them excited about it)

By Mark D Proulx, CQA, cSSBB on October 28, 2018

Most Quality people I know hear the same things over and over again. "Management isn't engaged." "Ma...

Quality vs Compliance Metrics (and what's next for FDA's Case For Quality)

By Nick Tippmann on October 21, 2018

What is the FDA looking to drive forward in its Case for Quality initiative?

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...

What it Means to be Focused on Quality vs. Compliance

By Jon Speer on September 30, 2018

Would you describe your company as quality focused?

Scaling Regulatory and Quality with Your Company

By Jon Speer on September 2, 2018

Have you thought about your systems and processes related to regulatory and quality standards?

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.

How to Design for Compliance with IEC60601

By Nick Tippmann on July 25, 2018

Have you ever designed a medical device that has electrical components? Was it frustrating to go thr...

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years

By Connor Remaley on July 10, 2018

Have you ever wondered what partnering with Greenlight Guru could mean for your business? We have a ...

Tips for Running Effective Internal Quality Audits

By Jon Speer on June 4, 2018

How did your last internal quality audit go? Internal audits can be a bit of a scramble in some comp...

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

By Nick Tippmann on May 25, 2018

We have many different types of companies using Greenlight Guru to help them create a compliant qual...

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