Chemical characterization plays a pivotal role in ensuring the safety of medical devices. The focus of this presentation is to share valuable insights and lessons learned from a manufacturer’s experiences in submitting chemical characterization data to the FDA.

We will discuss the regulatory requirements, challenges faced during submission, and best practices for successful submissions. Using real-world case studies, we aim to offer valuable guidance for experts in chemical characterization to navigate the complex regulatory landscape and improve patient safety and outcomes.

Presenter: Matthew R Jorgensen PhD, DABT

This presentation, by Matthew R Jorgensen, was recorded at the Open House seminar, in Leuven, in April 2023 and is part of a series of videos.