How do you create technical documentation that passes the notified body audit?

Technical documentation rarely fails on individual sentences; it fails on consistency across multiple documents. The notified body reviews the technical documentation under MDR/IVDR Annex II/III not as a loose collection, but as a coherent argument: the intended purpose must read the same in the device description, the IFU and the clinical evaluation. Every warning in the instructions for use must trace back to a residual risk from the risk management file per ISO 14971:2019. And the critical use scenarios from usability engineering per IEC 62366-1:2015 must be reflected in the instructions. If any one of these documents contradicts the others, the finding is inevitable, regardless of how well the individual text is written.

This is why the sequence matters: the IFU can only be written reliably once risk management and usability engineering have delivered the residual risks and use errors; if symbols and labelling are not built per EN ISO 15223-1:2021 and MDR Annex I Chapter III from the start, rework follows. We start at source reconciliation before the first sentence is written, and at the end we check all documents against one another in the consistency review. This shifts the effort to where corrections are cheap, rather than into the audit, where a deficiency request delays market access. It does not save documents, but it does save the expensive loops at the end of the project.