This session aims to provide a comprehensive understanding of Per- and Polyfluoroalkyl Substances (PFAS): what are they, why are they important, what regulatory changes can be expected in the coming years, and how can manufacturers begin preparing today. PFAS chemicals, known for their unique water- and grease-resistant properties, have become integral in various industrial processes, including the manufacturing of medical devices. PFAS regulations and restrictions represent the next wave on the global regulatory rollercoaster. As we work our way through MDR, PFAS will come closely on its tail. This presentation is intended to inform manufacturers on:
What are PFAS and why they are important to medical devices
Historical and current PFAS requirements
Types of products and materials that might be impacted by proposed regulations
Considerations of a testing strategy including study design, sample collection, and analysis
Real world examples on how manufacturers can take action today to prepare for proposed future restrictions
