Our Knee System products are approved FDA and CE,
I would like to know one thing regarding the Cleaning process, we would like to change the cleaning process center then what are the Re validations needed to our approved system?
As per our knowledge ,change in the cleaning process will affect the biocompatibility so we are thinking to do the biocompatibility tests and cleaning re validation .
My question is Do we need to do revalidation on sterilization (Gamma and Eto)?
I would like to know one thing regarding the Cleaning process, we would like to change the cleaning process center then what are the Re validations needed to our approved system?
As per our knowledge ,change in the cleaning process will affect the biocompatibility so we are thinking to do the biocompatibility tests and cleaning re validation .
My question is Do we need to do revalidation on sterilization (Gamma and Eto)?