The organization identifies and makes whatever changes are needed so that the quality management system stays suitable, adequate and effective and the medical device stays safe and performs as it should. It draws on the quality policy, the quality objectives, the results of audits, post-market surveillance, data analysis, corrective and preventive actions, and management review to do so.
This control maps to 2 controls across 2 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.