Design Verification & Validation Test Protocol Form

Design control template

Design Verification & Validation Test Protocol Form for medical device design controls

Use this editable Design Verification & Validation Test Protocol to run phase-gated design controls, keep your Design History File (DHF) complete, and demonstrate that your device was developed under controlled requirements.

Trace requirements to validationLink user needs, design inputs, outputs, V&V and transfer.

Support DHF integrityDocument reviews, changes and design transfer in one controlled flow.

Ready for FDA/MDR auditsAlign with 21 CFR 820.30 and MDR Annex I expectations.

Best for: DHF management, design planning, V&V evidence capture, design review and change control.
Includes: editable sections for inputs, outputs, planning, reviews, transfer, changes and V&V records.
Format: editable template available through the standard WooCommerce download flow.

Need the editable file?
Add the free template to cart

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:

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.

Template preview

Template preview: Design Verification & Validation Test Protocol

Review the key sections included in the Design Verification & Validation Test Protocol template before downloading it. This preview shows the structure and content you will receive in the editable file.

Download the editable template

View the full template preview

[Test description]

This form must be completed for all design verification or validation activities, whether conducted internally or externally. For external tests, a summary of the protocol must be documented in the appropriate sections. If multiple tests are covered by this protocol, each section should be structured by test.

Design verification

Design validation

Test performed internally

Test performed externally:

Laboratory Name:
Protocol reference:
Date:

Objective

State the purpose of the test and identify the related design inputs (for verification) or user requirements (for validation) as documented in the traceability matrix.

The objective of this test is to confirm that [Device Name] meets the design input / user requirement criteria identified as #X.Y and #Z.A, as listed in the traceability matrix [Document Ref, Revision].

Reference

The following reference standards, guidance documents, and/or internal procedures shall be used, as applicable, for the preparation and execution of the test. The relevant references are listed in the table below.

Reference	Description

List the applicable standards, test protocols, internal procedures, or regulatory documents used for this test.

Sample Selection

The following is the list of devices within [Device Name] range/family along with their characteristics that can affect the test results.

Device model	Feature 1	Feature 2	Feature 3	Feature X

Complete the table by listing each device model and the relevant characteristics that may influence the test results.

XXXX Describe how the selected device model(s) represent the product range/family for the purpose of this test. The justification shall include the critical characteristics that may affect the test outcome, such as size, configuration, material, design variant, operating principle, or other relevant parameters.

If the device is intended to be connected to, or have an interface with, other products (e.g., medical devices, accessories or other), the sample selection shall justify the configuration(s) selected to be representative of all relevant configurations.

In conclusion, the devices selected for the test are the following:

Device model	Description

Sampling Plan

The sampling plan was established based on the following method:

Indicate applicable standard/statistical method/risk-based approach/internal SOP.

Title	Document number	Revision

Accordingly, XXX samples will be used for each model selected according to the following justification:

Rationale for number of samples tested:

Testing Method

XXXX State the protocol or method used and briefly summarize the procedure, including sample preparation, test conditions, sequence, and equipment used.

/OR reference the method described in another document (e.g., from a specific instruction) and briefly summarize the procedure, test conditions, and equipment.

Reference applicable standards.

Acceptance Criteria

The design verification/validation activity is considered successful if the following acceptance criteria are met:

Test parameters	Acceptance criteria	Traceability to Design Inputs/User Requirements
		#X.Y indicate the DI/or UR
		#X.Y indicate the DI/or UR
		#X.Y indicate the DI/or UR
		#X.Y indicate the DI/or UR

Good practice: if the acceptance criterion is not defined/justified in the traceability matrix (e.g., for indirect parameters), the justification of the defined criteria must be indicated.

Conclusion

This protocol establishes the planned arrangements for the execution of the test, including the test objective, applicable references, sample selection, test method, and acceptance criteria. Following approval of this protocol, the test shall be executed as defined herein. The outcome of the test, including the results obtained, any deviations from the approved protocol during execution, and the conclusion on conformity with the applicable requirement(s), shall be documented in the associated test report.

The complete template content is displayed above. The editable file is available after adding the product to cart.

Free

Categories Featured documents, Quality documents

Design Verification & Validation Test Protocol Form