Description:

This test protocol template defines how we plan and document Design verification or Design validation to confirm requirements are met with objective evidence.
• Identify test type (Design verification / Design validation) and whether testing is internal or external (incl. Laboratory Name and Protocol reference).
• Define the Objective and link to the traceability matrix requirement IDs (#X.Y).
• List applicable Reference standards, guidance, and internal procedures used for execution.
• Justify Sample Selection across the device range/family (model and critical characteristics).
• Establish a Sampling Plan (method, rationale, and sample size per model).
• Summarize the Testing Method (conditions, sequence, equipment) and set measurable Acceptance Criteria.

Your needs:

• design verification test protocol aligned with ISO 13485 requirements
• design verification test protocol for project decision-making
• Reduce rework by locking acceptance criteria and sampling rationale before testing starts.

Use this template when you need a consistent, reviewable protocol prior to running a verification or validation test, internally or at an external laboratory, and before issuing the test report.

It captures the essentials in one place. Acceptance criteria define pass/fail thresholds linked to requirement IDs, and a risk-based sampling plan explains why the chosen number of samples is appropriate.
• Link each test parameter to the relevant DI/UR in the traceability matrix.
• Document device model selection and representative configurations.
• Record method, equipment, and test conditions for repeatability.
• Ensure criteria are justified when not already defined in traceability.
• Require a clear conclusion and deviations handling in the test report.

Within Lexqara, we support clinical documentation, regulatory submission readiness, design support, and audit preparation by turning protocols into DHF-ready evidence packages. Use our Resource Center and our Design Control Support for Start-up Companies, and align design control expectations with FDA design controls overview. Download the template or request a short protocol review.