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6 Predictions for the Medical Device Industry in 2019 (and how you can prepare) - Featured Image

6 Predictions for the Medical Device Industry in 2019 (and how you can prepare)

Within the past couple of years, we have experienced significant changes in the medical device indus...
FDA Plans to Modernize 510(k) - Is the Sky Falling? - Featured Image

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

Have you heard the news? FDA caused quite a stir when it recently announced transformative changes t...
ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body) - Featured Image

ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)

In less than four months, come March 2019, the transitional period for medical device companies to c...
FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing - Featured Image

FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing

What you’ve known and believed about computer system validation, software validation, and 21 CFR Par...
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...

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