Medical Device Quality, Regulatory and Product Development Blog

Defining Your Medical Device Design Records

By Jon Speer on December 18, 2018

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)

By Jon Speer on December 9, 2018

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?

By Nick Tippmann on December 5, 2018

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)

By ECM (Ente Certificazione Macchine) on December 5, 2018

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

By Jon Speer on December 2, 2018

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

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...

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

By Jon Speer on November 11, 2018

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

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