Traceability Matrix

Lexqara helps medical device manufacturers build robust design controls that satisfy both FDA QSR and EU MDR requirements. Explore the Resource Center or review our Design Control Services.

Description:
Use this Traceability Matrix to demonstrate end-to-end linkage across design requirements, evidence, and controls for a specific project/device.

• Define User Requirements (UR) with measurable Acceptance Criteria

• Record the Source of UR to justify each requirement

• Translate UR into Design Inputs (DI) with DI Acceptance Criteria

• Record the Source of DI to support each design input

• Link DI to Design Outputs (DO) with referenced Specification

• Capture Design Verification Report to confirm DO meets DI

• Capture Design Validation Report to confirm UR is fulfilled

• Document Process Control (Parameter, Specification, Control method) where applicable

Your needs:

• Design traceability matrix

• Design traceability matrix for MDR decision-making

• Reduce rework, strengthen audit readiness, and speed up design decisions

This document is used to maintain a clear, reviewable chain from user needs to design definition and evidence. Use it during design planning, design reviews, and whenever requirements or evidence change.

It covers requirements continuity and evidence completeness. Acceptance Criteria means the measurable condition that defines “pass” for a requirement; it matters because verification/validation results must be judged consistently. Source of UR/DI means where the requirement comes from; it matters because auditors expect objective justification.

• Unique IDs for UR, DI, DO

• Defined Acceptance Criteria for UR and DI

• Trace links UR→DI→DO

• Documented Design Verification Report

• Documented Design Validation Report

• Defined Process Control method and specs

At Lexqara, we help you tailor this matrix to your device, align it with your design control practices, and prepare objective evidence packages for reviews and audits. Get practical templates and examples in our Resource Center, and explore our Design Control support. For EU regulatory context, see the European Commission medical devices sector. Download the template and request a short gap assessment.