Design Verification

Turning design intent into proven performance requires a structured, compliant, and evidence-driven approach. At Heurnova Consulting, we ensure your medical device design meets defined requirements through robust verification planning, testing, and documentation strategies that align with ISO 13485, 21 CFR 820, and EU MDR expectations.

Our Design Verification services encompass the full lifecycle — from Verification Plan development and protocol creation to data analysis, report generation, and traceability confirmation. We help you establish objective evidence that your design outputs fulfill input requirements, integrating risk-based methods to ensure coverage of critical functions and safety elements.

Whether you’re verifying new designs, design changes, or legacy product updates, we tailor strategies that balance efficiency with regulatory rigor. Our team supports mechanical, electrical, and software verification activities, ensuring results are defensible, repeatable, and audit-ready.

Through structured documentation and seamless integration with design controls, Heurnova Consulting strengthens your compliance posture and builds the foundation for successful design validation, regulatory submission, and long-term product reliability.

Design Input & Output Traceability

Do you need clarity and confidence that your product design requirements directly map to measurable verification outputs? We establish a structured traceability framework linking design inputs, specifications, and intended use claims to testable, objective verification criteria. This ensures every requirement is validated, nothing is overlooked, and your verification scope remains both comprehensive and controlled.

You’ll receive a clear, audit-ready matrix that supports regulatory expectations, documentation needs, and internal design alignment — preventing rework, scope creep, or missing requirement coverage.

Deliverables we can provide include, but are not limited to:

Confirm design inputs are measurable, testable, and linked to user and regulatory requirements
Maintain a Design Traceability Matrix (DTM) mapping inputs to verification methods and results
Verify all design outputs meet the defined specifications prior to transfer to validation
Ensure updates to inputs trigger corresponding verification re-assessment

Verification Planning & Protocol Development

Not sure how to scope your verification activities so they are efficient, compliant, and appropriately justified? We develop verification test plans and detailed protocols that clearly define the verification approach, acceptance criteria, sample justification, test conditions, and responsibilities. This ensures that your verification strategy is aligned with regulatory requirements, product risk profiles, and engineering intent.

The result is a well-documented and defensible verification roadmap that avoids unnecessary testing while ensuring full coverage and readiness for audit review.

Deliverables we can provide include, but are not limited to:

Define verification objectives and acceptance criteria for each design input
Reference applicable standards (e.g., IEC 60601-1, ISO 10993, ISO 62366, ISO 14971)
Identify required test methods (analytical, inspection, functional, or simulated-use testing)
Align verification planning with DHF and QMS documentation requirements

Test Method Selection & Qualification

Unsure which test methods are appropriate — or whether they require validation or qualification? We evaluate testing needs and select the most appropriate industry, regulatory, or product-specific test methods to support your verification objectives. Where needed, we develop and execute method qualification activities to establish repeatability, reproducibility, and suitability. This ensures your test methods are both technically sound and regulatorily defensible, reducing the risk of failed audits or repeated testing.

Deliverables we can provide include, but are not limited to:

Determine whether test methods are standard, modified, or custom-developed
Validate any non-standard methods to ensure reliability and reproducibility
Confirm equipment calibration and environmental control for test accuracy
Ensure test facilities meet applicable accreditation or regulatory expectations

Execution & Data Collection

Need support overseeing or coordinating verification testing to ensure data integrity and traceability? We provide structured oversight of testing activities, ensuring test execution follows approved protocols, sample management is controlled, and all results are accurately documented.

Our approach emphasizes clarity, traceability, and objective data capture — reducing the risk of gaps, inconsistencies, or invalid results. You’ll receive complete data packages that are ready for acceptance review and regulatory inclusion.

Deliverables we can provide include, but are not limited to:

Verify that test samples are representative of production intent
Record test conditions, equipment, and personnel qualifications
Review and approve all deviations, nonconformances, and test anomalies
Store raw data and results in alignment with 21 CFR Part 11 and ISO 13485 data integrity requirements

Data Analysis & Acceptance Review

Not sure how to evaluate verification results against acceptance criteria with confidence and consistency? We perform detailed review and statistical evaluation of verification data to determine conformance with defined acceptance criteria. Findings are documented clearly, along with rationale for pass/fail decisions, observed trends, and any deviations requiring follow-up. This ensures verification conclusions are well-supported, transparent, and aligned with both engineering expectations and regulatory requirements.

Deliverables we can provide include, but are not limited to:

Perform statistical analysis of critical test data when applicable
Evaluate results against predefined specifications and tolerances
Document all failures, justifications, and corrective actions
Ensure objective evidence is traceable and reproducible

Reporting & Documentation Integration

Do you need your verification results clearly summarized and integrated into your design history documentation? We create structured verification reports that present methods, results, acceptance decisions, deviations, and justifications in a clear, audit-ready format. These reports are aligned with broader QMS documentation structures, ensuring seamless integration into Design History Files (DHF), technical files, and regulatory submissions. This improves clarity, traceability, and long-term maintainability of your design records.

Deliverables we can provide include, but are not limited to:

Summarize test objectives, methods, data, and results in structured reports
Include traceability references to design inputs, risk controls, and standards
Obtain cross-functional review and approval before DHF submission
Maintain version-controlled records aligned with QMS and regulatory documentation requirements

Post-Verification Review & Continuous Improvement

Want to ensure insights from verification activities are captured and used to improve future design processes? We conduct structured post-verification reviews to evaluate verification effectiveness, identify opportunities for design refinement, and strengthen verification strategies for future iterations. This includes developing improvement recommendations for protocol design, documentation clarity, and process efficiency. The result is a continuous improvement loop that enhances design robustness and reduces future verification burden.

Deliverables we can provide include, but are not limited to:

Evaluate lessons learned and implement design improvements proactively
Review unresolved nonconformances for CAPA or design change initiation
Update risk management files (ISO 14971) based on verification outcomes
Ensure verification practices remain current with regulatory expectations and product evolution

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