For each medical device type or family the organization establishes and maintains one or more files that contain or reference the documents generated to demonstrate conformity to the standard and compliance with applicable regulatory requirements. The file content includes at least a general description of the device, its intended use or purpose and labelling including instructions for use; product specifications; specifications or procedures for manufacturing, packaging, storage, handling and distribution; procedures for measuring and monitoring; and, as appropriate, installation requirements and servicing procedures.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.