In a global marketplace, many companies seek to launch their medical devices in multiple regions, serving patients and their physicians in numerous countries. However, within each area, there are typically varying guidelines and regulations that must be followed in order to sell product to that region.

Maintaining compliance with these policies falls to the quality and regulatory professionals at a company. They must ensure the practices of the organization for development, manufacturing, and post-market activities all remain aligned with the requirements of the country into which the product is being sold.

To help clarify the roles of these personnel and explain how an organization can maintain a focus on a global regulatory strategy, Lisa Perronne, Vice President, Quality & Regulatory, at Elevaris Medical Devices, took time to respond to the following series of questions. In this Q&A, she defines the two distinct roles, offers insights on “first to launch,” and comments on post-market surveillance, while also tackling other topics.

Sean Fenske: Quality and regulatory are often grouped together. What is the difference between the two? What are the most important aspects of each?

Lisa Perronne: These two activities highly complement each other and, thus, are sometimes…