The manufacturer shall maintain records of the process parameters for the sterilization process which was used for each sterilization batch. Sterilization records shall be traceable to each production batch of medical device. Validation of processes for production and service provision: 7.5.2.1 General 7.5.2 The manufacturer shall validate any processes for production and service provision where t ...

Design and development validation: Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches or their equivalence. Design v ...