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Understanding the Blurred Lines Between Consumer Tech and MedTech - Featured Image

Understanding the Blurred Lines Between Consumer Tech and MedTech

Did you know that the Apple Watch was recently granted de novo classification requests by the FDA? P...
3 Real World Document Management Horror Stories - Featured Image

3 Real World Document Management Horror Stories

In the medical device world, it’s not uncommon to get hung up on documentation. “It takes too much t...
Understanding The Differences Between Clearance vs Approval vs Granted - Featured Image

Understanding The Differences Between Clearance vs Approval vs Granted

Are you confused by regulatory terminology? Clearance. Approval. Granted.
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)!

Are you a smart, talented and ambitious individual looking to be surrounded by other elite performer...
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...
Streamlining The Device Marketing Authorization Process - Featured Image

Streamlining The Device Marketing Authorization Process

There are a few additional steps to take when it comes to the Medical Device Single Audit Program (M...
ISO 13485 - Ultimate Guide to Quality Management Systems (QMS) for Medical Devices - Featured Image

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

            TABLE OF CONTENTS Overview Evolution of Quality Systems General Requirements Documentati...
The New Special 510(k): What You Need To Know - Featured Image

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

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)

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

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

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)

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

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