<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">

Greenlight Guru Medical Device Blog

GET THE LATEST UPDATES FROM OUR BLOG:

Join 150,000+ other medical device professionals outperforming their peers.

Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices - Featured Image

Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices

By Taylor Brown on November 23, 2021
In the European Union, in vitro diagnostic (IVD) devices are governed by a specific set of regulatio...
Explaining IVDR Classification for In Vitro Medical Devices - Featured Image

Explaining IVDR Classification for In Vitro Medical Devices

By Wade Schroeder on November 19, 2021
The In Vitro Diagnostic Regulation (IVDR), which concerns in vitro diagnostic medical devices in the...
What are the SaMD Requirements from FDA? - Featured Image

What are the SaMD Requirements from FDA?

By Wade Schroeder on November 10, 2021
The market for software as a medical device (SaMD) is growing rapidly as more companies see the poss...
What is a Class 2 Medical Device in the US? - Featured Image

What is a Class 2 Medical Device in the US?

By Tom Rish on November 2, 2021
The goal of anyone involved in medical devices is simple: produce high quality products that improve...
What is a Class 1 Medical Device? - Featured Image

What is a Class 1 Medical Device?

By Tom Rish on October 8, 2021
In the US, the governing body tasked with regulating the medical device market is the Food and Drug ...
How are Medical Devices Classified under EU MDR? - Featured Image

How are Medical Devices Classified under EU MDR?

By Laura Court on July 23, 2021
One of the most important steps in bringing a medical device to market in the European Union (EU) is...
Understanding the FDA Medical Device Classification System - Featured Image

Understanding the FDA Medical Device Classification System

By Ryan Behringer on July 16, 2021
The world of medical devices is one of the most varied and complex industries around today. Innovati...
Examining the HHS Proposal for Premarket Notification Exemptions - Featured Image

Examining the HHS Proposal for Premarket Notification Exemptions

By Nick Tippmann on June 7, 2021
What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS...
Why is IVDR Causing Widespread Panic throughout the Medical Device Industry? - Featured Image

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

By Nick Tippmann on May 6, 2021
Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many devic...
Why the PMA Process is so Dreaded by Manufacturers in the US Market - Featured Image

Why the PMA Process is so Dreaded by Manufacturers in the US Market

By Nick Tippmann on March 15, 2021
Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that h...
What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD) - Featured Image

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

By Nick Tippmann on May 20, 2020
Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end u...
Documentation Priority for Early Stage Medtechs — Part 1: User Specification - Featured Image

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

By Tommy Cooper on April 19, 2020
A common dilemma for early stage medical device companies is their lack of expertise in medical devi...

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...
© 2022 Greenlight Guru
Third party trademarks, logos and trade names appearing on the site are the property of their respective owners. Legal