Technical file basics
How to prepare and structure your technical documentation
8 guides
What belongs in the technical fileUnderstand the core evidence areas Complya expects for MDR or IVDR technical documentation.Prepare source documents before uploadCollect and name the files that help Complya draft and your expert review efficiently.Supported upload formats and quality tipsUse readable files and avoid scans that hide important evidence from extraction.Review AI-drafted documentsTreat generated documents as drafts that need source checking and expert sign-off.Answer missing-information requestsResolve manufacturer-only gaps in a way your expert can review and approve.Understand document status labelsKnow what each of the six document status labels means.Export the delivery bundleDownload the expert-reviewed output once the case has been released.Keep evidence and generated documents alignedUnderstand when a source change should trigger regeneration or expert re-review.