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

Medical Device Industry Predictions for 2019

By Nick Tippmann on December 19, 2018

It’s time to recap what happened in the medical device industry this year and start to think about w...

FDA Plans to Modernize 510(k) - Is the Sky Falling?

By Nick Tippmann on December 5, 2018

Have you heard the news? FDA caused quite a stir when it recently announced transformative changes t...

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...

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...

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...

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 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?

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