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