EU MDR Technical Documentation
Keeping Risk, Clinical and Design Records Consistent Through Product Changes
- Product configuration as the basis for documentation consistency
- Change impact across design, materials, software, suppliers, and manufacturing
- Alignment of risk controls, clinical conclusions, and design records
- Verification and validation evidence after product changes
- Applicability, effectivity, and revision state of existing evidence
- Identifying missing, stale, conflicting, or incorrect relationships
- Configuration-centered assessment before approving technical documentation changes
- EU MDR technical documentation readiness for Notified Body review
A product change can affect risk, clinical, design, and verification records differently, making relationship-based impact assessment essential before technical documentation is updated.
This session structures change assessment around product configuration, helping maintain alignment among design information, risk controls, clinical conclusions, verification evidence, and regulatory records.
The session begins with product configuration as the reference point for technical documentation, then follows change impact across connected design, risk, clinical, and verification information. It examines applicability, effectivity, revision state, and objective evidence to determine whether existing conclusions remain valid and where controlled information requires coordinated updates.
José Ignacio Mora brings over 30 years of medical device and life sciences experience across manufacturing engineering, quality systems, process development, and product realization. His leadership roles at Boston Scientific and Stryker Orthopedics provide practical grounding for assessing how product changes affect design information, manufacturing configurations, supporting evidence, and the consistency of regulated technical documentation.