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

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

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

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?

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

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)

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

By Tommy Cooper on April 19, 2020

A common dilemma for early stage medical device companies is their lack of expertise in medical devi...

How to Choose the Right FDA Regulatory Pathway for your Device

By Nick Tippmann on February 26, 2020

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...

7 FDA Pathways to Bring Your Medical Device to Market

By Tom Rish on February 16, 2020

Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...

Medical Device Classification Guide - How To Determine Your Device Class

By Tom Rish on January 2, 2020

What I am about to share with you is a guide to medical device regulatory classification.

This is a What … Unforeseen Pitfalls when Classifying a Medical Device

By John F. Johnson III on April 7, 2017

“This is a what” is not only a torturous summer-camp game, but an essential question when working to...

You do know Design Controls are required for medical devices, right?

By Jon Speer on September 9, 2014

So you're developing a medical device? Congratulations!

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