Use literature and clinical investigation evidence

For literature evidence, record the search strategy, inclusion and exclusion criteria, appraisal approach, and why each source is relevant to the device, indication, population, and clinical claims.

For clinical investigations, provide protocols, reports, endpoints, population details, adverse events, deviations, and conclusions. The expert will look for whether the evidence actually supports the intended purpose and claims.

Avoid mixing evidence levels without explanation. Bench tests, usability studies, literature, and clinical investigations can all be useful, but they answer different questions.