Common use of Process Validation Clause in Contracts

Process Validation. Project approach to Process Validation will be done according to Cordis Quality System, The Sterilization strategy is to be 3X EtO capable, which will be the same as current marketed devices (self expandable stents), Previous Cordis validations will be leveraged for sterilization. DV/PPQ units for both product and its packaging for the 18 new Carotid Stent Delivery System catalogs - 65cm length will be subjected to three EtO sterilization cycles, See License Agreement for Complaint Handling and FAL.