Validation of design and development follows planned, documented arrangements and confirms that the finished product can satisfy what its intended use or specified application demands. The organization documents validation plans giving methods, acceptance criteria and, where appropriate, statistical techniques with the reasoning for the sample size. Validation is done on representative product, such as initial production units or batches or their equivalents, and the reasons for that choice are recorded. Clinical or performance evaluations of the device form part of validation, carried out as the relevant regulatory requirements demand; a device supplied for such an evaluation does not count as released to the customer. Where the intended use needs the device to connect or interface with other devices, validation must show the requirements are satisfied in that connected state. Validation must be finished before the product is released to the customer for use, and records of its results, conclusions and any actions are kept.
This control maps to 6 controls across 4 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 6 it maps to, and the evidence behind each claim, over MCP and REST.