For every medical device type or family, the organization keeps a design and development file. The file holds, or points to, the records produced to show the design and development requirements were met, together with the records of any changes made to the design.
This control maps to 7 controls across 5 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 7 it maps to, and the evidence behind each claim, over MCP and REST.