Where installation is required, records of installation and its verification must be kept. Servicing must follow defined, implemented instructions and procedures, be documented, and service records must be used as quality data in measurement, analysis and improvement. Brazil: service records must show the product, its control number, completion date, service provider, work done and inspection and test results, and must be reviewed periodically, with CAPA started where trends pose danger or records involve death or serious injury (RDC 665/2022 Arts 129, 130). United States: service reports must give the device name, UDI or UPC and other identifiers and control numbers, and the service date (21 CFR 820.35(b)). Clauses: ISO 13485:2016 4.2.1, 7.5.3, 7.5.4, 8.4; RDC 665/2022 Arts 125, 126; MO169 Arts 6, 42, 43, 61.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.