The manufacturer shall establish and maintain a record for each batch of medical device or in vitro diagnostic medical devices that provides traceability and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved. 7.5.1.2 Control of production and service provision—Specific requirements 7.5.1.2.1 Cleanliness of product and contamin ...

Records of validation shall be maintained. 7.5.2.2 Particular requirements for sterile medical devices The manufacturer shall establish documented procedures for the validation of sterilization processes. Sterilization processes shall be validated prior to initial use. The records of validation of each sterilization process shall be maintained. 7.5.3 Identification and traceability: