Presenter: Alpa Patel, Principal Scientist (Nelson Laboratories LLC)
Reprocessing validations of reusable medical devices have been overlooked for quite some time and the importance of these validations for medical device manufacturers has taken a back seat until recently. The upcoming MDR requirements and added US FDA scrutiny over reusable medical devices has shed a light on the importance and significance of validations. The presentation will highlight some of the key aspects of what is required for validation studies for reusable medical devices and how to perform these validations. It will give a perspective of what is needed to include in these validations and where in the design phase these validations make their presence. Alpa Patel explains the importance of cleaning and disinfection validations as well as sterilization validations.