Reprocessing of Reusable Medical Devices

Over the past few years, the requirements for reprocessing have steadily increased, covering areas such as reprocessing instructions, procedures, validation studies, and more. As many manufacturers target multiple markets, including both the European and US FDA markets, it is crucial to account for the varying regulatory frameworks and guidelines. The testing strategy for validation must be planned accordingly.

Additionally, reprocessing over the product lifecycle and the evaluation of additional parameters at the end of the lifecycle have become a "hot topic." This webinar will compare the different requirements for US FDA submissions and Notified Bodies regarding reprocessing. Approaches to address both sets of requirements in validation studies, when possible, will be outlined. Challenges and pitfalls encountered in numerous projects will be shared, and strategies for meeting lifecycle expectations will be discussed.