Medical Device Quality, Regulatory and Product Development Blog

Understanding the Blurred Lines Between Consumer Tech and MedTech

By Nick Tippmann on November 28, 2018

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

By Jon Speer on November 25, 2018

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

By Nick Tippmann on November 21, 2018

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

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

By Nick Tippmann on November 20, 2018

Are you a smart, talented and ambitious individual looking to be surrounded by other elite performer...

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...

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...

ISO 13485 - Ultimate Guide to Quality Management Systems (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): 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...

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