Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers

With the forthcoming restrictions on Per- and Polyfluoroalkyl Substances (PFAS), medical device manufacturers are on the brink of a significant industry shift. PFAS, known for their versatile properties, have been integral in the production of various medical devices. However, with the phase-out of these substances by the end of 2025, manufacturers must navigate the transition with precision and strategic foresight.

This session will begin with a short presentation to set the stage, and will be followed by a panel discussion bringing together RQM+'s leading experts in regulatory affairs, quality assurance, and lab services, to delineate a proactive approach for manufacturers.

We will dissect the three-step process required to phase out PFAS used in medical devices, addressing the identification of alternative materials, the intricacies of materials testing and verification, and the critical steps for successful documentation submission to regulatory bodies.

Key points of discussion: 

• Identification of Alternatives: Insights into how manufacturers can identify and source PFAS-free materials for medical devices, including potential redesign considerations. 
• Testing and Validation: An overview of the materials testing, validation, and documentation process required to ensure compliance and maintain device quality and safety. 
• Regulatory Strategy: Guidance on the submission of documentation to government agencies such as the FDA, and how to align with global regulatory expectations, including significant changes in the EU. 
• Strategic Planning: Best practices for project management and ensuring a seamless transition, while minimizing disruptions to supply chains and operations. 

Join us as we chart out the roadmap for an industry facing one of its most challenging transitions, ensuring that your devices remain compliant, safe, and on the leading edge of innovation.

RSVP by completing the form and we'll email connection details.

Panelists: 

• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation
• Kevin Rowland – Director of R&D
• Taryn Meade – Director of Biological Evaluation Consulting
• James Wrenn – Director of Solutions Delivery
• Alexia Haralambous – Senior Principal (former FDA) [Newly added!]

BONUS: If you want to get the most out of the session, be sure to watch this primer from by Jai beforehand. This video outlines the basics, and we'll dive deeper and answer your questions during the discussion.