For implantable medical devices, traceability records include records of the components, materials and work environment conditions used where these could cause the device not to satisfy its specified safety and performance requirements. The organization requires suppliers of distribution services or distributors to maintain records of distribution that allow traceability and to make them available for inspection. Records of the name and address of the shipping package consignee are maintained.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.