Verification and Validation (V&V) are paired processes used to confirm that a medical device has been designed correctly and meets its intended purpose. Verification demonstrates that design outputs meet design inputs, while validation confirms that the finished device satisfies user needs under actual or simulated use conditions.
Together, these activities provide objective evidence that the device is safe, effective and suitable for its intended users and operating environment.
What Is Verification and Validation?
Although verification and validation are closely connected, they answer different questions:
- Verification: Did we build the device according to its specifications?
- Validation: Did we build the correct device for the user and intended clinical application?
Verification evaluates drawings, software, components, specifications and other design outputs against measurable requirements. Validation evaluates the complete device against documented user needs and its intended use.
A device may pass every dimensional, electrical and software test but still fail validation if users cannot operate it safely or it does not perform effectively in its intended environment.
Why V&V Matters in Medical Device Development
Verification and validation are essential parts of medical-device design controls. They help manufacturers identify design problems before the product is transferred to production or submitted for regulatory approval.
Inadequate V&V can result in patient-safety risks, regulatory findings, delayed submissions, expensive redesigns, field failures and product recalls. Finding an unclear requirement during validation is significantly more costly than correcting it before formal testing begins.
V&V results also form important evidence within the device’s technical file or design and development file. Regulators and notified bodies use these records to evaluate whether requirements, risks and performance claims have been adequately addressed.
How the V&V Process Works
V&V begins with approved, measurable design inputs and a defined risk-management process. Each requirement should have an acceptance criterion and an appropriate verification or validation method.
1. Develop the V&V Plan
The V&V plan defines:
- Requirements and features to be tested
- Verification and validation methods
- Test responsibilities and required resources
- Sample sizes and statistical rationale
- Acceptance criteria
- Test equipment and environmental conditions
- Required protocols, reports and approvals
- Handling of deviations and failed results
Planning should begin early enough to identify requirements that are ambiguous, incomplete or impossible to test objectively.
2. Verify the Design Outputs
Verification confirms that each design output meets its corresponding design input. Methods may include inspection, analysis, demonstration and testing.
Depending on the device, verification activities may include:
- Dimensional and mechanical testing
- Electrical safety testing against IEC 60601
- EMC testing
- Biocompatibility evaluation
- Environmental and reliability testing
- Packaging and transportation testing
- Software verification under IEC 62304
- Battery, alarm and performance testing
Formal testing should use approved protocols with predefined acceptance criteria. Results, deviations and conclusions must be documented in controlled reports.
3. Validate the Finished Device
Design validation confirms that the complete device satisfies user needs and performs as intended. Testing should use production units, initial production units or their documented equivalents.
Validation is conducted under actual or simulated use conditions and may include clinical evaluation, simulated-use studies, performance testing and usability engineering. Representative users should participate when device safety or effectiveness depends on user interaction.
4. Connect V&V to Risk Management
Risk-control measures must be verified to demonstrate that they were implemented correctly and are effective. Validation should also confirm that the device’s overall residual risk remains acceptable when used as intended.
Any new hazard or failure discovered during testing must be evaluated through the benefit-risk determination and risk-management process.
5. Maintain Traceability
A Requirements Traceability Matrix connects user needs, design inputs, design outputs, risk controls, verification tests and validation results.
Bidirectional traceability helps demonstrate that every requirement has been addressed and that every test can be traced to an approved requirement. It also makes the impact of requirement or design changes easier to evaluate.
Verification Versus Process Validation
Design validation and process validation are not the same.
Design validation demonstrates that the finished device meets user needs and its intended purpose. Process validation demonstrates that a manufacturing process can consistently produce conforming products when its results cannot be fully verified through subsequent inspection or testing.
Process validation commonly uses Installation Qualification, Operational Qualification and Performance Qualification—known as IQ, OQ and PQ. It normally occurs during design transfer and production preparation.
Common V&V Challenges
A frequent problem is using vague requirements such as “easy to operate” or “sufficiently durable.” These statements must be translated into measurable acceptance criteria before testing.
Other common issues include:
- Beginning formal testing before the design is sufficiently stable
- Using prototype units that are not representative of production
- Changing acceptance criteria after reviewing test results
- Selecting sample sizes without documented justification
- Failing to investigate test deviations
- Missing links between requirements, risks and test evidence
- Reusing previous test data without assessing design changes
Formal change control should determine whether a modification requires additional verification, validation or risk assessment.
How SJML Supports Verification and Validation
SJML integrates V&V into its end-to-end medical device design and engineering process, from concept development and product architecture through detailed design, testing and design transfer.
Its multidisciplinary capabilities include mechanical, electronics, embedded software, systems engineering, risk management and usability engineering. In-house infrastructure supports electrical safety, EMC, reliability, environmental and endurance testing.
SJML can help develop V&V strategies, protocols, traceability records and reports while maintaining alignment between requirements, risk controls and regulatory documentation.
Contact SJML’s engineering team to discuss verification and validation support for your medical-device program.
Frequently asked questions
Verification confirms that design outputs meet design inputs, using bench methods like inspection, test, or analysis against engineering specifications. Validation confirms that the finished device meets user needs and intended use, tested on production-equivalent units under real or simulated conditions. Verification asks whether the device was built to spec; validation asks whether it is the right device for its users.
The primary standard is ISO 13485:2016, with design verification in Section 7.3.6 and design validation in Section 7.3.7. These are incorporated by reference into FDA 21 CFR Part 820 under the Quality Management System Regulation effective February 2, 2026. EU MDR 2017/745 requires equivalent evidence, and product standards such as IEC 60601-1, IEC 62304, and IEC 62366-1 define specific test requirements.
No. Design validation confirms the device meets user needs and intended use, and it belongs to the design controls phase. Process validation (IQ, OQ, PQ) confirms that a manufacturing process can consistently produce conforming devices, and it belongs to design transfer and production. Both are required, but they answer different questions at different lifecycle stages.
Verification begins once design inputs are defined, and design outputs exist to test against them. Validation follows, on production-equivalent units, before the device is released to full production. V&V precedes design transfer, so that design defects are caught before manufacturing scales. Results feed the design history file and the technical documentation reviewed by regulators.
