Technical Documentation & Risk File Review
Find the gaps before an auditor does.
Technical files accumulate. Requirements change, documents are updated in isolation, and traceability quietly breaks. The gap between what a file claims and what it can evidence often surfaces at the worst possible moment.
AVRA reviews existing documentation and identifies missing, inconsistent, or unsupportable evidence, with findings prioritized by regulatory exposure.
AVRA supports
- Technical-file completeness and internal-consistency review
- Traceability across requirements, verification, and validation evidence
- ISO 14971 risk-management file structure and hazard-analysis review
- IEC 60601 family conformity-documentation review
- Prioritized findings report with a remediation sequence
Scope: This is a review and strengthening service for existing documentation. For ground-up design history file construction on novel devices, AVRA coordinates with specialist partners.
Experience behind the service
Preparation, review, and control of technical files, IFUs, and risk-related documentation across a 44-registration portfolio, including technical liaison work with TÜV Rheinland on certification pathways.