2023-10-17T05:40:48
Note: Configuration management is a means by which
identification and traceability can be maintained.
7.5.3.2.2 Particular requirements for active implantable medical
devices and implantable medical devices
In defining the records required for traceability, the
manufacturer shall include records of all components,
materials and work environment conditions, if these could
cause the medical device not to satisfy its specified
requirements.
The manufacturer shall require that its agents or distributors
maintain records of the distribution of active implantable
medical devices and implantable medical devices to allow
traceability and that such records are available for inspection.
Records of the name and address of the shipping package
consignee shall be maintained.
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