Review AI-drafted documents

AI-drafted documents help assemble a first version of the technical file, but they are not a substitute for manufacturer responsibility or expert review. Read generated text against the source citations and confirm that it reflects the current device.

Pay particular attention to classification, intended purpose, clinical claims, patient-contacting materials, risk controls, and regulatory status statements. These areas can affect downstream obligations and should be corrected early.

When Complya flags a gap, answer it in the workflow rather than editing around it. A structured answer can be reviewed, approved, and reused consistently across related documents.