Video Library

Currently Viewing: Peggy McLaughlin

Gauss Surgical: Regulatory Landscape for the Triton System

Milt McColl, CEO, and Peggy McLaughlin, VP of Regulatory Affairs, discuss the initial regulatory landscape for Gauss Surgical’s Triton fluid management system and how the company ended up on the de novo pathway.

Related Videos

Gauss Surgical: Embarking on the De Novo Pathway

Milt McColl, CEO, and Peggy McLaughlin, VP of Regulatory Affairs for Gauss Surgical, describe some of the challenges associated with their switch to the de novo pathway.

Related Videos

Gauss Surgical: Addressing Clinical Risk

Milt McColl, CEO, and Peggy McLaughlin, VP of Regulatory Affairs for Gauss Surgical, share their experience amassing clinical evidence and addressing risks as part of their regulatory process.

Related Videos

Gauss Surgical: Managing the De Novo Process

Milt McColl, CEO, and Peggy McLaughlin, VP of Regulatory Affairs for Gauss Surgical, share some of their experiences in managing their de novo submission.

Related Videos

Gauss Surgical: Challenges and Lessons from the De Novo Process

Milt McColl, CEO, and Peggy McLaughlin, VP of Regulatory Affairs for Gauss Surgical provide lessons and tips based on their experience on the de novo pathway.

Related Videos

Identifying an Appropriate Regulatory Expert

Regulatory consultant Peggy McLaughlin describes an approach for identifying experts well-suited to work on a specific project.

Related Videos

What Changes Underway at FDA Seem Most Pro-Innovation?

Two regulatory experts and a former FDA lead reviewer share their perspective on changes underway at the agency that may help medtech innovators.

Related Videos

What Should Innovators Know About Meeting with FDA?

A regulatory consultant and a former FDA lead reviewer provide tips to help innovators maximize their effectiveness when meeting with representatives from the FDA.

Related Videos