Reprocessing validations of reusable medical devices have often been overlooked. However, the upcoming Medical Device Regulation (MDR) requirements and increased scrutiny from the US FDA have highlighted their importance and significance. This webinar will address the critical aspects required for validation studies of reusable medical devices and provide guidance on how to perform these validations effectively.
Hosted by Lise Vanderkelen, the presentation will focus primarily on cleaning validation for reusable devices, offering a detailed overview of the necessary steps to ensure compliance with both MDR and FDA standards. Viewers will gain a comprehensive understanding of the specific requirements and best practices for conducting reprocessing validations, ensuring that reusable medical devices are safe, effective, and compliant with regulatory expectations.
The session will begin by discussing the significance of reprocessing validations in the context of the new MDR and the heightened scrutiny from the FDA. Participants will learn why these validations are now more critical than ever and how they contribute to the overall safety and effectiveness of medical devices.
By the end of this webinar, attendees will be equipped with the knowledge and tools needed to perform comprehensive reprocessing validations for reusable medical devices. This session is essential for quality assurance professionals, regulatory affairs specialists, and anyone involved in the reprocessing and validation of medical devices. By understanding and implementing the best practices discussed, participants will be better prepared to navigate the complexities of reprocessing validations and ensure their devices meet the highest standards of safety and compliance.