Verification & Validation
SaMD Validation Leadership
Frelong Health supports the design and execution of verification and validation strategies for Software as a Medical Device (SaMD). We contribute directly to validation planning, protocol development, and execution to ensure testing activities produce a clear and defensible record of system performance and clinical safety.
Risk-Based Testing Frameworks
Effective validation prioritizes what matters most. We help organizations implement risk-based testing strategies that align verification activities with clinical risk and regulatory expectations. Automated regression suites and targeted testing approaches are used to support efficient V&V cycles while maintaining strong safety assurance.
Distributed Testing Environments
Modern development teams are often distributed. Frelong Health assists in establishing standardized testing environments that allow quality teams to perform consistent validation activities across locations. This includes guidance on high-performance testing workstations, virtualized environments, and hardware-in-the-loop configurations when required.
AI-Augmented Development Practices
Emerging AI tools are increasingly being integrated into the software development lifecycle. Frelong Health works with teams to evaluate and responsibly implement AI-assisted capabilities such as automated test generation, intelligent defect identification, and prioritization of testing based on code-change impact.
Statistical Validation Planning
Verification and validation activities must generate results that support regulatory confidence. We assist teams in applying appropriate statistical methods to determine sample sizes, acceptance criteria, and confidence levels needed to demonstrate system reliability and performance.
Automated Testing Architecture
Sustainable software quality requires scalable automation. Frelong Health supports the design and maintenance of automated testing frameworks that evolve alongside development. These systems provide a reliable validation safety net and reduce manual testing burden over time.
Program and Supplier Alignment
Complex development programs often involve multiple teams and external suppliers. Frelong Health helps coordinate validation expectations across organizations to ensure consistent testing practices, clear quality requirements, and alignment with regulatory standards.
Frequently Asked Questions
Common questions about verification and validation (V&V), IEC 62304 testing requirements, risk-based strategies, and traceability for regulated digital health systems.
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Verification and validation (V&V) are processes used to confirm that software meets specified requirements (verification) and fulfills its intended use in a clinical context (validation). For Software as a Medical Device (SaMD), V&V must be documented and traceable to support regulatory review.
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A risk-based testing strategy prioritizes verification activities based on clinical and system risk. Higher-risk features receive more rigorous testing, ensuring that safety-critical functionality is thoroughly verified and validated.
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IEC 62304 defines lifecycle requirements for medical device software, including verification planning, test execution, and documentation. It ensures testing activities are structured, repeatable, and aligned with software safety classification.
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Regulated V&V requires documented test plans, protocols, execution records, traceability matrices, and summary reports. These artifacts must demonstrate that all requirements and risk controls have been properly verified.
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Traceability links requirements, risk controls, and test results to ensure complete test coverage. Regulators expect end-to-end traceability to demonstrate that all safety-critical functions have been validated.
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Yes, automated testing is widely used to support scalable and repeatable verification activities. However, automated tests must be validated, documented, and integrated into a controlled lifecycle to ensure regulatory acceptance.
Common Questions by Service
How do I build an ISO 13485-compliant QMS for digital health?
Structured QMS systems must align documentation, risk management, and lifecycle controls from the start.
Explore QMS Systems
What should be included in a Design History File (DHF)?
A defensible DHF connects requirements, risk controls, and verification evidence into a traceable system.
View DHF Review Services
How should software be developed in a regulated digital health environment?
Software must be developed within a controlled lifecycle aligned to IEC 62304, with structured requirements, traceability, risk integration, and verification activities.
Explore Software Development
How do I address cybersecurity in regulated medical software?
Cybersecurity requires structured threat modeling, risk controls, and ongoing monitoring aligned to FDA expectations.
Learn About Cybersecurity Compliance
How should CAPA investigations be structured in a regulated QMS?
CAPA investigations must demonstrate clear root cause analysis, risk evaluation, and defensible corrective actions aligned to regulatory expectations.
Explore CAPA Engine
How do I prepare my QMS for an MDSAP audit?
MDSAP readiness requires aligned procedures, audit-ready documentation, and clear traceability across quality system processes.
Explore MDSAP Readiness
A strong 510(k) requires structured documentation, clear substantial equivalence, and defensible verification and validation evidence.
View 510(k) Strategy & Submission
Verification & Validation
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Design It.
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.
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Execute It.
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.
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Defend It.
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.