The manufacturer of medical device software demonstrates the ability to provide software that consistently meets customer and applicable regulatory requirements, typically through a quality management system complying with ISO 13485, a national quality management standard or one national regulation requires, with ISO/IEC 90003 as guidance for applying quality management to software.
This control maps to 2 controls across 1 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 2 it maps to, and the evidence behind each claim, over MCP and REST.