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

Understanding the Premarket Approval (PMA) Process

By Tom Rish on July 26, 2021

Before any medical device can hit the US market, FDA must first evaluate the product’s potential ris...

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...

Preparing Your Pre-Submission with the Content FDA Wants to See

By Nick Tippmann on June 23, 2021

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...

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...

Top 100 Medical Device Acronyms & Terminology You Need to Know

By Jon Speer on July 19, 2020

In the medical device industry, knowledge is power. Your knowledge of medical device terminology emp...

What is Regulatory Due Diligence for Medical Devices?

By Nick Tippmann on June 24, 2020

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory s...

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

By Nick Tippmann on June 3, 2020

Most of us have read about, observed, participated in, and spoke with healthcare providers and medic...

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

By Nick Tippmann on May 6, 2020

What does the 510(k) process involve? How should medical device companies know if this is the right ...

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...

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

By Tom Rish on November 3, 2019

As a medical device professional, you are well aware of how much time and effort goes into getting y...

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)

By Nick Tippmann on May 15, 2018

When developing a new medical device, do you try to figure out the fastest and simplest way to get y...

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