Recently, on my company, we have started to develop a new medical device class IIb which presents a sensors that needs reprocessing, including sterilization performed by the healthcare professional (hydrogen peroxide)
We have already contacted a laboratory that will perform the validation, but they have requested a sterilization validation plan, and this is something we have no experience at all.
Does someone have any example or template on this kind of validation? I assume this is not a design validation, it would look more like a process validation? What about the concept validation master plan? Is it the same?
We have already contacted a laboratory that will perform the validation, but they have requested a sterilization validation plan, and this is something we have no experience at all.
Does someone have any example or template on this kind of validation? I assume this is not a design validation, it would look more like a process validation? What about the concept validation master plan? Is it the same?