2023-10-17T05:39:59
7.5.3.1 Identification
The manufacturer shall identify the product by suitable means
throughout product realization, and shall establish documented procedures for such product identification. The manufacturer shall establish documented procedures to ensure that medical devices and in vitro diagnostic medical devices returned to the manufacturer are identified and distinguished from conforming product.
7.5.3.2 Traceability
7.5.3.2.1 General
The manufacturer shall establish documented procedures for
traceability. Such procedures shall define the extent of
product traceability and the records required.
Where traceability is a requirement, the manufacturer shall
control and record the unique identification of the product.
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