Thanks for the information. I have one question as below - Is it necessary to do Cleaning and disinfection process validation for Non-sterile low risk Class Ir device. Can we just provide cleaning and disinfection instructions similar to predicate device manufacturer . If yes, whether it will be accepted.
Thanks for the information. I have one question as below -
Is it necessary to do Cleaning and disinfection process validation for Non-sterile low risk Class Ir device. Can we just provide cleaning and disinfection instructions similar to predicate device manufacturer . If yes, whether it will be accepted.