Medical Devices
IVDR Readiness: Documentation Discipline That Prevents Fire Drills
February 7, 2026 • 7 min read
IVDR readiness is often delayed by fragmented document ownership. Teams assume content exists, then discover gaps during formal review.
Documentation discipline model
- Assign single-point accountability per critical file class.
- Enforce controlled templates and version history.
- Introduce pre-review checkpoints before major milestones.
- Track dependencies between technical, clinical, and quality records.
Risk reduced
Fire drills happen when dependencies are implicit. Make them explicit and governed.