Description:

This document defines how we capture and conclude design verification or design validation evidence in a consistent test report.
• Select Design verification or Design validation and state internal/external execution (Laboratory Name).
• Record Protocol reference, Report reference, and Date for traceability.
• Define the Objective linked to requirement IDs in the traceability matrix (#X.Y).
• List applicable Reference standards, guidance, and internal procedures used.
• Document Deviations and justify why results remain valid.
• Confirm Sample Selection, Sampling Plan, and rationale for sample size.
• Maintain Product Traceability (samples, equipment, materials, IDs/lots/serials).
• Report Test Results, Pass/Fail, corrective actions/design change, and attachments.

Your needs:

• design verification test report aligned with ISO 13485 requirements
• design verification test report for project decision-making
• Reduce audit risk with clear pass/fail evidence and deviation control.

Use this report after executing an approved protocol to document results, deviations, and conclusions against the defined requirements, with attachments for raw test data where needed.

It supports consistent decision-making. Deviations are any departures from the approved protocol and must be justified; Product Traceability links what was tested to identifiers so results remain defensible.
• Link each parameter to DI/UR IDs in the traceability matrix.
• Confirm the acceptance criteria applied are measurable and justified.
• Summarize results and clearly indicate Pass/Fail per criterion.
• Record observations and justification for unmet criteria.
• Define corrective actions or design changes when needed.

At Lexqara, we help align your protocols, reports, and DHF evidence so verification/validation outputs stay coherent across design control and audits. Explore our Resource Center and our Design Control Support for Start-up Companies, and benchmark design control expectations via FDA Design Controls. Request a short report gap assessment.