Maintaining Traceability Between User Requirements, Risk Controls and Verification Evidence
- Traceability matrix versus maintained product configuration
- Requirements, risks, design outputs, and verification relationships
- Controlled states, revisions, applicability, and effectivity
- Identifying missing, stale, broken, or incorrect relationships
- Change impact assessment across connected configuration objects
- Maintaining traceability as products and configurations change
- Generating controlled traceability views from approved information
- Inspection readiness through configuration integrity and objective evidence
Traceability decisions become more demanding when requirements, risks, design outputs, verification evidence, and approved product configurations change at different points in the lifecycle.
This session structures traceability around maintained configuration relationships, improving change impact assessment, relationship integrity, evidence management, and inspection readiness across evolving products.
The session begins by distinguishing traceability matrices from maintained product configuration, then examines the objects, relationships, states, and applicability that make traceability reliable. It progresses into identifying relationship gaps, assessing change impact, maintaining configuration integrity, and generating controlled traceability views from approved information rather than reconstructing connections across separate documents.
José Ignacio Mora brings over 30 years of medical device and life sciences experience spanning manufacturing engineering, quality systems, process development, validation, and product realization. His leadership roles at Boston Scientific and Stryker Orthopedics provide practical grounding for connecting requirements, risk controls, design changes, verification evidence, and approved product configurations throughout the device lifecycle.