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Technical File
How to prepare and structure your technical documentation
What belongs in the technical file
Understand the core evidence areas Complya expects for MDR or IVDR technical documentation.
Prepare source documents before upload
Collect and name the files that help Complya draft and your expert review efficiently.
Supported upload formats and quality tips
Use readable files and avoid scans that hide important evidence from extraction.
Review AI-drafted documents
Treat generated documents as drafts that need source checking and expert sign-off.
Answer missing-information requests
Resolve manufacturer-only gaps in a way your expert can review and approve.
Understand document status labels
Know the difference between not started, drafted, awaiting input, issued, and stale documents.
Export the delivery bundle
Download the expert-reviewed output once the case has been released.
Keep evidence and generated documents aligned
Understand when a source change should trigger regeneration or expert re-review.