A technical file is the evidence package that supports conformity. It usually includes device description, intended purpose, classification rationale, GSPR or requirement traceability, risk management, clinical or performance evidence, PMS planning, labelling, IFU, manufacturing and QMS-relevant information, and declarations or certificates where applicable.
Complya organizes this evidence by case and document type. AI can help draft and structure documents, but source evidence and expert review remain essential: a generated section is not stronger than the evidence behind it.
Start with current controlled documents rather than outdated drafts. If source evidence changes after drafting, the affected generated documents may need to be regenerated or re-reviewed.
Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.