Design Verification & Validation
Build and manage complete V&V programmes — requirements traceability matrix from specification to test result, test method selection, functional safety verification, non-conformance management, and certification-ready evidence management in PLM using the EMUG TRACE Framework.
Design Verification & Validation for Engineering Organisations
Design Verification & Validation for Engineering Organisations
Design verification and validation is the structured programme of activities that confirms every product requirement is met — design verification demonstrating the design output meets its specification, and design validation demonstrating the product performs correctly in its intended use environment. EMUG Tech delivers V&V programmes for automotive OEMs, aerospace manufacturers, industrial equipment producers, and energy companies across 20 countries using the EMUG TRACE Framework — covering IATF 16949, AS9100, ISO 26262, IEC 61508, DO-178C, and EU type approval.
Most engineering organisations have the test data they need for product certification — what they are missing is the requirements traceability matrix that links each test result to the requirement it verifies. Without traceability, test evidence cannot demonstrate requirements compliance to regulatory authorities or quality system auditors — it demonstrates only that tests were run. EMUG TRACE builds traceability from requirements analysis before testing begins, ensuring every test is designed to verify a specific requirement against a defined acceptance criterion.
CORE CAPABILITIES
EMUG Tech's design V&V capability spans seven specialised service areas — from requirements traceability and V&V Master Plan development through test method selection, design verification execution, design validation execution, functional safety V&V, and PLM-integrated evidence management.
Requirements Traceability Matrix Development
Full RTM development from requirements analysis — reviewing system specifications, customer requirements, applicable standards, and regulatory requirements to map every requirement to a verification method, acceptance criterion, test level, and responsible function. Coverage gap identification and orphan requirement detection. RTM stored in PLM linked to the specification revision.
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V&V Master Plan Development
V&V Master Plan defining the complete test programme scope — virtual test events (FEA, CFD, HIL, SIL, MIL), physical test events (component, subsystem, system), inspection activities, and analysis tasks. Programme schedule aligned to product development milestones and regulatory submission dates. Resource and facility plan. Risk assessment for safety-critical test events.
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Design Verification Programme Execution
Managing design verification activities confirming design output meets design input requirements — test procedure development, test witness and data review at critical events, real-time pass/fail assessment against acceptance criteria, and non-conformance management with root cause analysis and re-test planning. IATF 16949 and AS9100 verification record preparation.
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Design Validation Programme Execution
Managing design validation demonstrating product performance in the intended use environment — customer use case coverage, prototype and pre-production test programme, field validation, and end-user evaluation. Validation evidence package preparation for IATF 16949 design validation, AS9100 design verification, and EU type approval submission.
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Functional Safety V&V (ISO 26262 / IEC 61508)
ISO 26262 and IEC 61508 functional safety verification covering hardware (FMEDA, fault injection, diagnostic coverage testing), software (unit test, integration test, back-to-back testing, MC/DC structural coverage), and system validation (fault injection at system level, reaction time verification). ASIL-appropriate verification depth and evidence documentation for TUV and SGS functional safety assessment.
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Non-Conformance and Failure Management
Structured test failure management — non-conformance record creation with failure description, test conditions, and measurement data; root cause analysis using 8D, Ishikawa, and fault tree methodology; corrective action definition with engineering change reference; re-test planning and execution; and non-conformance closure with evidence. Preventing test failures from being recorded without root cause and corrective action.
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V&V Evidence Management in PLM
PLM-integrated V&V evidence management — storing test procedures, raw data, analysis reports, and sign-off records in Teamcenter, Windchill, or 3DEXPERIENCE linked to the certified design revision. RTM maintained in PLM with test result references and compliance status. Audit-ready evidence dashboard showing requirement coverage and open verification items across active programmes.
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KEY METRICS
Design Verification and Validation Programmes Delivered Across Automotive Aerospace and Industrial
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The EMUG TRACE Framework — Our Design Verification & Validation Methodology
EMUG designs and delivers all design V&V programmes using the EMUG TRACE Framework — five phases covering Trace, Review, Assess, Conduct, and Evidence. TRACE ensures V&V programmes start with requirements traceability analysis, select test methods matched to requirement risk level, manage non-conformances to root cause, and produce certification documentation that meets regulatory authority submission standards.
1
TRACE
Requirements traceability analysis and V&V scope definition — reviewing the complete product requirements set from system specifications, customer requirements, applicable standards (IATF 16949, AS9100, ISO 26262, IEC 61508, DO-178C, DO-254), and regulatory requirements to build the requirements traceability matrix (RTM) mapping every requirement to a verification method, acceptance criterion, test level, and responsible engineering function. Identifying requirements with no current verification method, duplicate requirements, and conflicting acceptance criteria. Deliverable: Requirements Traceability Matrix (RTM) with Coverage Assessment and Gap Identification Report.
2
REVIEW
Test method selection and V&V Master Plan development — reviewing the RTM with engineering, systems, and product leads to select the optimal verification method for each requirement from the hierarchy: test (physical or simulation), inspection (measurement or review), demonstration (function observation), or analysis (calculation or modelling). Balancing verification rigour against programme cost, timeline, and prototype availability. Building the V&V Master Plan with test schedule aligned to product development milestones and regulatory submission dates. Deliverable: V&V Master Plan with Test Method Allocation and Programme Schedule.
3
ASSESS
Test programme planning and resource assessment — developing detailed test procedures for each physical and virtual test event: test setup, instrumentation requirements, environmental conditions, pass/fail criteria, data recording requirements, and safety considerations for hazardous test events. Test facility and equipment reservation, calibration certificate verification, test article procurement status review, and risk assessment for safety-critical test events with hazard mitigation planning. Deliverable: Test Procedures, Resource Plan, Equipment Calibration Register, and Test Safety Risk Assessment.
4
CONDUCT
Verification and validation test execution — managing and supporting virtual test execution (FEA, CFD, HIL, SIL, MIL), physical test execution (component, subsystem, system level), and inspection and analysis activities. Test witness and data review at critical test events. Real-time pass/fail assessment against acceptance criteria. Non-conformance management: documenting test failures with failure description, test conditions, and data, initiating root cause analysis, and managing re-test planning and execution. Deliverable: Test Execution Records, Raw Test Data, and Non-Conformance Register.
5
EVIDENCE
Results analysis, certification documentation, and V&V evidence management — analysing test data and simulation results against acceptance criteria, correlating physical test results to simulation predictions, assessing margin to requirement limits, preparing verification and validation summary reports meeting regulatory submission requirements, and storing all V&V evidence in PLM linked to the certified design revision. Requirements traceability matrix updated with test result references and compliance status. Deliverable: V&V Summary Report, Completed RTM, Certification Documentation Package, and PLM Evidence Archive.
DESIGN V&V SERVICE MATRIX
| V&V Service Area | Primary Engineering Outcome | Standards and Framework | Key Deliverables |
|---|---|---|---|
| Requirements Traceability Matrix | Every requirement has a verification method and acceptance criterion. Coverage gaps identified before test programme start. Regulatory RTM requirement met. | IATF 16949 cl.8.3.4, AS9100 cl.8.3.4, ISO 26262 Part 4, DO-178C, DO-254, FDA design controls | RTM document, coverage heatmap, gap analysis report, regulatory requirements mapping |
| V&V Master Plan Development | Complete test programme scope defined. Virtual and physical test balance optimised. Programme schedule aligned to development milestones. | IATF 16949 APQP, AS9100 design planning, ISO 26262 confirmation measures, DO-178C PHAC | V&V Master Plan, test method allocation matrix, programme schedule, resource plan |
| Design Verification Programme | Design output conformance to design input requirements demonstrated. Verification evidence complete for quality system audit. | IATF 16949 cl.8.3.4.3, AS9100 cl.8.3.4, ISO 26262 Part 4 confirmation measures | Verification test procedures, test records, results analysis, verification summary report |
| Design Validation Programme | Product performance in intended use environment demonstrated. Customer use case coverage complete. Validation evidence ready for regulatory submission. | IATF 16949 cl.8.3.4.3, AS9100 cl.8.3.5, ISO 26262 validation testing, EU type approval | Validation test procedures, customer use case coverage, validation summary, prototype test records |
| Functional Safety V&V (ISO 26262, IEC 61508) | Functional safety requirements verified at each architectural level. Safety case argument supported by confirmation measure evidence. | ISO 26262 Parts 4, 5, 6 (hardware/software V&V), IEC 61508 Parts 3 and 4, IEC 61511 | Safety requirement verification records, FMEA verification, fault injection test results, functional safety assessment support |
| V&V Evidence Management in PLM | All V&V evidence stored in PLM linked to certified design revision. RTM accessible to quality auditors. Evidence package regulation-ready. | Teamcenter Simulation Manager, Windchill ProductPoint, 3DEXPERIENCE test objects, PLM lifecycle integration | PLM-stored test records, RTM in PLM, evidence package linked to design revision, audit-ready evidence dashboard |
EMUG's design V&V programmes are calibrated for five key engineering sectors — with industry-specific requirements traceability frameworks, functional safety standards expertise, and regulatory authority submission knowledge pre-built for each sector's certification environment.
INDUSTRY ALIGNMENT
Automotive OEMs & Tier 1 Suppliers
IATF 16949 design verification and validation — RTM, V&V Master Plan, APQP phase verification, prototype and pre-production validation programme. ISO 26262 functional safety confirmation measures for ASIL A through ASIL D systems. PPAP design validation evidence preparation. EU type approval test evidence compilation.
Aerospace & Defense
AS9100 Rev D design verification records and review evidence. DO-178C software verification — requirements traceability, code coverage analysis, and structural coverage for DAL A through DAL D. DO-254 hardware design verification. EASA Part 21 compliance evidence package and DOA support.
Industrial Machinery & Equipment
ISO 9001 design verification and validation for CE-marked machinery. IEC 61508 functional safety verification for safety-critical control systems. Machinery Directive essential health and safety requirement verification evidence. ATEX equipment design verification for explosive atmosphere products.
Energy, Oil & Gas
Pressure equipment directive (PED) design verification evidence management. IEC 61511 safety instrumented system verification — SIL verification, proof test procedure development, and PFD/PFH calculation validation. ASME and EN pressure vessel design verification evidence management and third-party review support.
Medical Devices
ISO 13485 design verification and validation — design output to design input traceability, design verification test records, clinical evaluation support, and design validation protocol and report preparation. FDA 21 CFR Part 820 design controls compliance — DHF design history file compilation and 510(k) design validation evidence.
VALUE PROPOSITION
| RTM built from requirements analysis — not assembled from completed test results | EMUG TRACE builds the requirements traceability matrix before test programme execution begins — analysing the complete requirements set, assigning verification methods, and identifying coverage gaps while there is still time to add test coverage. Building the RTM after testing is complete produces a traceability record, not a verification plan — and cannot identify the requirements that were never tested. |
| Test method selection balancing rigour with programme cost | EMUG TRACE Review phase selects verification methods from the four-method hierarchy (test, inspection, demonstration, analysis) matching the risk level and regulatory requirement for each requirement — using simulation where it provides sufficient evidence to avoid expensive physical tests, and reserving physical test resource for requirements where simulation confidence is insufficient or where regulatory authorities require physical test data. |
| ISO 26262 and IEC 61508 functional safety V&V expertise | EMUG Tech’s functional safety engineers manage ISO 26262 confirmation measures across all ASIL levels — hardware verification (FMEDA, fault injection), software verification (unit test, integration test, back-to-back testing), and system validation testing — producing the safety case evidence that functional safety assessment bodies require for TUV and SGS compliance certification. |
| Non-conformance management to root cause — not just recorded | Every test failure in an EMUG TRACE programme triggers a structured non-conformance record: failure description, test conditions, measurement data, failure mode hypothesis, root cause analysis using 8D or Ishikawa methodology, corrective action with engineering change reference, and re-test plan. Test failures that are recorded without root cause analysis produce a compliance record but not a product improvement. |
| V&V evidence stored in PLM — traceable to the certified design revision | EMUG TRACE stores all V&V evidence in PLM — test procedures, raw data, analysis reports, and sign-off records — linked to the specific design item revision they certify. When an engineering change is released, the system identifies which V&V evidence was produced for the previous revision and which verification activities must be repeated for the new design, preventing the silent gap where changed designs are assumed to inherit previous test results. |
| Certification documentation prepared to regulatory authority submission standard | EMUG TRACE Evidence phase prepares verification and validation documentation to the submission standard of the applicable regulatory authority — UNECE homologation submissions, EU type approval technical files, EASA Part 21 design evidence packages, and FDA 510(k) design validation reports — reducing authority review cycles and securing approval on the first submission. |
Frequently Asked Questions
Expert answers from EMUG Tech's Design Verification & Validation practice.
EMUG Tech’s design V&V service covers the complete verification and validation lifecycle: requirements traceability matrix development mapping every product requirement to a verification method and acceptance criterion; V&V Master Plan development aligning the test programme to development milestones; test procedure development for physical and virtual test events; test programme execution management with non-conformance control; functional safety V&V for ISO 26262 and IEC 61508 programmes; and V&V evidence management in PLM linked to the certified design revision. The service follows the EMUG TRACE Framework — Trace, Review, Assess, Conduct, and Evidence — and covers IATF 16949, AS9100, ISO 26262, IEC 61508, DO-178C, and EU type approval requirements.
EMUG TRACE is the five-phase design verification and validation methodology: Trace — requirements traceability analysis, RTM development, and coverage gap identification; Review — test method selection and V&V Master Plan development; Assess — test procedure development, resource planning, and safety risk assessment; Conduct — test programme execution with real-time pass/fail assessment and non-conformance management; Evidence — results analysis, certification documentation, and PLM evidence archiving. TRACE addresses the most common V&V failure: organisations that execute tests without a requirements traceability matrix and discover, at regulatory audit, that requirements exist with no corresponding test evidence.
A requirements traceability matrix (RTM) is a document that links every product requirement to the verification method that will demonstrate compliance, the acceptance criterion that defines pass/fail, the test level at which verification will occur (component, subsystem, system), and the test result that demonstrates the requirement is met. RTMs are mandatory because IATF 16949 clause 8.3.4 requires design and development verification to confirm design outputs meet design input requirements; AS9100 clause 8.3.4 requires design verification activities; ISO 26262 Part 4 requires confirmation measures for every safety requirement; and regulatory type approval authorities require evidence that every requirement in the approval basis has been verified. An RTM produced before testing identifies coverage gaps that can be addressed; an RTM produced after testing is a traceability record that cannot fix uncovered requirements.
EMUG TRACE Review phase selects verification methods from four options for each requirement: test — physically or virtually demonstrating compliance under defined conditions (the most rigorous method and required by most safety and regulatory standards for critical requirements); inspection — measuring or examining a design characteristic to confirm it meets the specification (used for dimensional, material, and configuration requirements); demonstration — observing a function or operation to confirm it performs as specified (used for operational requirements where measurement is not practical); and analysis — using calculation, simulation, or modelling to predict compliance (used where physical testing is impractical or where simulation provides sufficient evidence). Method selection balances verification rigour (regulatory requirements and safety criticality) against programme cost and timeline.
Functional safety verification for ISO 26262 (automotive) and IEC 61508 (industrial) confirms that safety requirements at every architectural level are correctly implemented and that the achieved failure rate metrics (ASIL decomposition targets, diagnostic coverage, PFH values) are demonstrated through analysis and test evidence. EMUG Tech delivers functional safety V&V covering: hardware verification — FMEDA analysis producing random hardware failure metric results, hardware integration test, fault injection testing demonstrating diagnostic coverage; software verification — software unit testing, integration testing, back-to-back testing, and structural coverage measurement (MC/DC for ASIL D); and system validation testing — fault injection at system level confirming safety mechanisms activate correctly and within the required fault reaction time.
EMUG TRACE manages test non-conformances through a structured process triggered by any test failure: immediate non-conformance record creation documenting failure description, test conditions at failure, measurement data, and test article status; failure mode hypothesis generation by the test and engineering team; root cause analysis using appropriate methodology (8D, Ishikawa, fault tree analysis) with depth appropriate to safety criticality; corrective action definition with engineering change reference and expected verification impact; re-test plan specifying the test conditions, test article status, and acceptance criteria for re-verification; and re-test execution with result recorded in the non-conformance record as closed or escalated. Non-conformances that cannot be resolved trigger design change or requirement deviation management.
EMUG TRACE stores V&V evidence in PLM using the simulation and test result management structures of each PLM platform: in Teamcenter, test records are stored as Simulation objects linked to the Item Revision they verify, with the requirements traceability matrix maintained as a Dataset linked to the specification Item Revision; in Windchill, test records are stored as Windchill documents or ProductPoint test objects linked to the Part configuration; in 3DEXPERIENCE, test evidence is stored as simulation objects in the ENOVIA structure linked to the relevant Product and Configuration. The PLM structure provides the complete traceability chain from requirement specification through verification method, test procedure, test result, and compliance status — accessible to quality auditors through standard PLM access control without requiring access to engineering CAD systems.
Design verification and validation programmes are delivered across automotive OEMs and Tier 1 suppliers (IATF 16949, ISO 26262), aerospace and defense manufacturers (AS9100, DO-178C, EASA Part 21), industrial machinery producers (ISO 9001, IEC 61508), energy companies (IEC 61511, ATEX), and medical device companies (ISO 13485, FDA design controls) in 20 countries: Germany, France, UK, Netherlands, Sweden, Italy, Spain, Poland, Czech Republic in Europe; India, Japan, South Korea, China, Malaysia, Thailand in Asia-Pacific; UAE and Saudi Arabia in the Middle East; USA, Canada, Mexico, Brazil in the Americas.
V&V That Starts with Requirements — Not with Tests.
Connect with EMUG Tech's V&V specialists to assess your current requirements traceability coverage, scope your V&V programme, and define the TRACE Framework delivery plan for your next product certification.
Advancing industries requires reimagining how products are designed, built and optimised at scale.
Automotive & Mobility
Engineering solutions for electric vehicles, connected mobility platforms, and next-generation automotive product development.
Aerospace & Defense
Advanced engineering support for aerospace and defense programs, ensuring safety, precision, and performance.
Industrial & Heavy Engineering
Engineering expertise for heavy machinery, industrial equipment, and complex mechanical systems development.
Manufacturing & Smart Factory
Smart manufacturing solutions enabling Industry 4.0 automation, digital factories, and efficient production systems.
Energy & Sustainability
Engineering solutions supporting renewable energy systems, sustainable infrastructure, and efficient power technologies.
Rail, Transportation & Infrastructure
Engineering services for rail systems, transportation networks, and large-scale infrastructure development projects.
Consumer Products & Appliances
Product engineering for consumer electronics and appliances focused on innovation, quality, and reliability.
Hi-Tech, Electronics & Semiconductors
Engineering solutions for semiconductor technologies, electronics design, and high-tech product innovation.
Aerospace Manufacturing & MRO
Engineering support for aerospace manufacturing, maintenance, repair, and aircraft lifecycle management.
Emerging & Future Industries
Engineering and digital innovation enabling next-generation technologies and future-focused industry development.
Every Requirement Verified. Every Test Traceable. Every Certification Defensible.
Partner with EMUG Tech to plan and deliver your design verification and validation programme — requirements traceability, test method selection, functional safety V&V, and certification-ready evidence management in PLM using the EMUG TRACE Framework.
