The organization has documented procedures for identifying product, and identifies product by appropriate means from start to finish of product realization. Throughout production, storage, installation and servicing, it identifies where product stands against its monitoring and measurement requirements, so that product is dispatched, used or installed only when it has passed the inspections and tests required or has been released under an authorized concession. When regulatory requirements call for it, the organization documents a system for giving the medical device its unique device identification. It also documents procedures that keep returned medical devices identified and separate from product that conforms.
This control maps to 15 controls across 14 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 15 it maps to, and the evidence behind each claim, over MCP and REST.