Recent feedback from global regulatory bodies has increasingly emphasized the necessity of extractables and leachables (E&L) chemistry testing for all medical devices, including those with limited contact duration. This evolving regulatory landscape presents new challenges for manufacturers aiming to ensure compliance while maintaining efficient development processes.
This presentation will highlight the latest regulatory feedback received from global authorities regarding E&L testing requirements. Attendees will gain a comprehensive understanding of why even devices with limited contact duration are now subject to stringent E&L testing mandates. The session will provide insights into the rationale behind these regulatory demands and the potential risks they aim to mitigate.
Furthermore, the presentation will offer practical guidance on how to navigate these regulatory expectations and avoid the pitfalls of the “Limited Device E&L Trap.” Participants will learn about effective strategies for designing and conducting E&L studies that meet regulatory standards without unnecessary complexity or cost. This includes selecting appropriate testing methodologies, understanding regulatory criteria, and implementing best practices for data interpretation and reporting.
By addressing these critical aspects, the presentation aims to equip medical device manufacturers with the knowledge and tools needed to ensure their products comply with the latest E&L testing requirements. This proactive approach not only helps in avoiding regulatory issues but also enhances the overall safety and quality of medical devices.
This presentation is essential for professionals involved in the development, testing, and regulatory compliance of medical devices. By attending, participants will gain valuable insights into current regulatory trends and learn how to effectively manage E&L testing to meet global standards, ensuring the safety and efficacy of their products.