Medical Device Quality, Regulatory and Product Development Blog

Streamlining The Device Marketing Authorization Process

By Nick Tippmann on November 14, 2018

There are a few additional steps to take when it comes to the Medical Device Single Audit Program (M...

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...

The New Special 510(k): What You Need To Know

By Nick Tippmann on November 7, 2018

Have you heard the recent buzz about the FDA’s supposed new Special 510(k) Pilot Program? Is it real...

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...

What's New With PMAs

By Nick Tippmann on October 31, 2018

How do you feel about pre-market approval (PMA) for Class III medical devices?

Greenlight Guru Announces New Integration with Jira Software

By Nick Tippmann on October 31, 2018

Quality management software platform for medical device companies now integrates with industry-leadi...

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...

How to Efficiently Raise Funds for Your Medical Device Company

By Nick Tippmann on October 24, 2018

Are you in the midst of raising funds for a device that you are trying to bring to market? It can be...

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?

7 Habits of Highly Effective True Quality Medical Device Professionals

By Nick Tippmann on October 17, 2018

What is true quality? How do you achieve it?

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...

Greenlight Guru Medical Device Blog