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

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

By Jon Speer on November 11, 2018
            TABLE OF CONTENTS Overview Evolution of Quality Systems General Requirements Documentati...
The New Special 510(k) - Featured Image

The New Special 510(k)

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) - Featured Image

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 - Featured Image

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 - Featured Image

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) - Featured Image

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 - Featured Image

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) - Featured Image

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 - Featured Image

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 - Featured Image

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...
Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring (Again)! - Featured Image

Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring (Again)!

By Nick Tippmann on October 10, 2018
Are you a smart, talented and ambitious individual looking to be surrounded by other elite performer...
Regulatory Tips & Strategies from a Former FDA Reviewer - Featured Image

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...

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