Verification begins long before execution.

We evaluate your V&V Master Plan, safety classification, and lifecycle documentation to ensure testing scope aligns with software risk classification and intended use.

We assess:

• Requirements-to-test coverage completeness
• Risk-to-test mapping integrity
• Safety classification alignment
• Verification depth proportional to risk
• Traceability matrix structure
• Configuration and baseline control

Weak V&V architecture creates regulatory vulnerability.

We ensure your validation strategy is structured before test execution begins.

Testing without traceability is noise.

We support structured execution through:

• Unit, integration, and system test protocol review

• Risk-based test prioritization

• Regression strategy alignment

• Acceptance criteria clarity

• Configuration-controlled test records

• Validation report defensibility

Every requirement must be testable.

Every test must be traceable.

Every failure must be documented and resolved through controlled processes.

We ensure your verification evidence tells a coherent technical story.

FDA reviewers and auditors look for patterns.

They assess whether validation demonstrates:

• Logical requirement coverage

• Adequate risk control verification

• Proper anomaly resolution

• Justified acceptance criteria

• Structured release approval

We provide structured V&V gap analysis and hands-on remediation support to:

• Close traceability gaps

• Strengthen risk verification alignment

• Rebuild incomplete test documentation

• Prepare validation summaries for submission

Whether preparing for 510(k), De Novo, PMA, or ISO certification, we ensure your V&V framework is defensible under scrutiny.

Evidence-based. Traceable. Inspection-ready.