Greenlight Guru Medical Device Blog

GET THE LATEST UPDATES FROM OUR BLOG:

Join 68,000+ other medical device professionals outperforming their peers.

Defining Your Medical Device Design Records - Featured Image

Defining Your Medical Device Design Records

It’s easy to get a bit confused when you consider the records that are required for your medical dev...
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...
Ultimate Guide to ISO 13485 Quality Management System (QMS) for Medical Devices - Featured Image

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

            TABLE OF CONTENTS What is ISO 13485 Evolution of a Quality Management System ISO 13485 C...

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

Our Most Popular Posts

Topics

See More Topics...