Design Verification & Validation Test Report Form

[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 and results must be documented in the appropriate sections. If multiple tests are covered by this report, each section should be stratified by test.

Design verification	Design validation
Test performed internally Protocol reference:	Test performed externally: Laboratory Name: Report 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 were used for the preparation, execution, and assessment of the test.

Reference	Description

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

Deviations

The test was executed according to the approved protocol

Deviations	No deviation observed	Deviation(s) observed (see below)
	Description of the deviation	Justification for validity of results

For each deviation from the approved protocol, describe the deviation and justify why the validity of the test results is not adversely affected. If no deviation occurred, select “No deviation observed”.

Deviations may concern sample preparation, test equipment, conditions, method, etc.

Sample Selection

The justification of sample selection is defined in the design verification/validation protocol: XXXX Include the protocol number and revision.

/OR

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 as 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:

Product Traceability

Product description	Identification (if applicable)	Traceability (if applicable)
Test samples
Measuring equipment
Equipment
Materials
Other

List all device models, test samples, measuring equipment, or materials used, including their lot/serial number for traceability, as necessary (remove non-applicable items)

Testing Method

See protocol number: XXXX. Briefly summarize the method applied, including sample preparation, test conditions, and equipment used.

Reference applicable standards.

/OR

XXX Reference the approved protocol and summarize the method actually applied, including any relevant execution conditions and deviations, if applicable.

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.

Test Results

Summarize the test results in a clear, tabular or narrative format.

Indicate whether each acceptance criterion was met. Include any necessary justification and describe corrective actions for unmet criteria.

Attach raw test data as needed.

Tests
Test method reference
Data summary	Description of results, inclusion of pictures, etc.
Key Results	Test parameters Acceptance criteria Results Pass/ Fail
Observations / Justification for unmet criteria
Conclusion	Pass Fail
Corrective actions/design change
Attachments	XXX XXX

Duplicate the table if multiple tests are considered under the same report.

Conclusion

The requirements for [describe the type of test] are [met/ not met]. The test [confirms / does not confirm] compliance of [Device Name] with the design inputs, #X.Y, #Z.A / user requirements #X, #Y.

Only if one or more criteria are not met (otherwise remove):

All acceptance criteria were met, except the following:

Test	Acceptance Criteria	Result	Justification or proposed action

XXXXX Include an overall summary.