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Summary

You must create comprehensive plans that systematically verify your medical device meets design specifications and validate it fulfills user needs and intended use requirements. Verification and validation planning establishes the testing roadmap that proves you built the device correctly and built the right device for its intended medical purpose.

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Regulatory Context

Under 21 CFR Part 820.30 (Design Controls), you must implement:
  • Design verification per Section 820.30(f) confirming design outputs meet design inputs
  • Design validation per Section 820.30(g) ensuring devices meet user needs and intended use
  • Statistical techniques per Section 820.250 for determining sample sizes and acceptance criteria
  • Software validation per FDA guidance for devices containing software components
  • Risk-based testing focusing resources on safety-critical device functions
Special attention required for:
  • Software as Medical Device validation per FDA SaMD classification framework
  • Cybersecurity validation for networked devices per FDA premarket guidance
  • Clinical validation requirements for novel devices or new indications
  • Predicate device comparison for substantial equivalence demonstration in 510(k) pathway

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Overview

Verification and validation planning represents the strategic foundation for systematically proving your medical device is both built correctly and suitable for its intended medical purpose through comprehensive testing activities that demonstrate regulatory compliance and clinical effectiveness. This planning process transforms abstract requirements into concrete testing strategies that provide objective evidence of device safety, effectiveness, and quality. Verification and Validation Strategy Development establishes your overarching approach to proving device compliance by distinguishing between verification activities that confirm design outputs meet design inputs and validation activities that demonstrate the complete device meets user needs and intended use requirements. Your strategic approach must address hardware verification through electrical safety and performance testing, software verification through systematic code and system testing, biocompatibility evaluation for patient-contacting materials, usability validation through human factors testing, and clinical validation when required for device effectiveness claims. Software System Test Planning creates systematic approaches for verifying that your software components function correctly according to specifications while integrating safely with hardware and user interfaces. Software testing plans must address functional testing of software requirements, performance testing under various load conditions, security testing for cybersecurity risks, integration testing between software components, and regression testing to ensure changes don’t introduce new defects. The planning process must consider Software of Unknown Provenance (SOUP) components, automated versus manual testing strategies, and test environment management that supports reproducible results. Performance and Bench Testing Planning establishes methodologies for demonstrating that your device meets essential performance characteristics under various operating conditions. These plans must specify test methods that objectively measure device performance against specifications, environmental testing that confirms operation under intended use conditions, durability testing that validates device lifetime expectations, and accuracy testing that demonstrates measurement capabilities meet clinical requirements. Performance testing planning must consider statistical approaches for sample size determination and acceptance criteria that provide confidence in device capability. Biological Evaluation Planning addresses biocompatibility assessment for devices that contact patients directly by establishing testing strategies according to ISO 10993-1 based on contact type, duration, and exposure pathways. The planning process must consider existing biocompatibility data for materials, testing requirements specific to your device’s patient contact profile, and integration with risk management to address biological risks. Biological evaluation planning may reduce testing requirements through appropriate use of existing data while ensuring comprehensive safety assessment. Verification and Validation Protocol Development translates strategic testing approaches into detailed, executable procedures that specify test methods, sample requirements, acceptance criteria, and documentation standards. Protocol development requires careful consideration of testing sequence dependencies, resource requirements, timeline constraints, and outsourced testing coordination. Each protocol must reference applicable standards, justify testing approaches, and establish clear pass/fail criteria that support regulatory decision-making. Electrical and Shelf-Life Testing Planning ensures that your device meets electrical safety requirements per IEC 60601 series standards and maintains performance throughout its intended shelf life and operational lifetime. Electrical testing planning must address basic safety, essential performance, electromagnetic compatibility, and cybersecurity requirements while shelf-life planning validates device stability, packaging integrity, and performance degradation over time. These specialized testing areas require coordination with risk management to address identified electrical and aging-related hazards. Testing Resource and Timeline Management coordinates all verification and validation activities to optimize testing efficiency while meeting development milestones and regulatory submission deadlines. Resource planning must consider laboratory capacity, testing equipment availability, sample preparation requirements, and results analysis timelines. Effective planning identifies critical path testing activities and develops contingency approaches for testing delays or failures that could impact development schedules. Acceptance Criteria Development establishes objective, measurable standards for determining test success that align with device specifications, user needs, and regulatory requirements. Acceptance criteria must be clearly defined before testing begins to prevent subjective interpretation disputes and ensure consistent evaluation across all testing activities. The criteria development process requires statistical consideration of measurement uncertainty, device variability, and clinical relevance of performance parameters. Documentation and Traceability Planning ensures that all verification and validation activities generate appropriate documentation that supports regulatory submissions and demonstrates systematic compliance with design control requirements. Documentation planning must address test report formats, data management procedures, traceability matrix maintenance, and change control integration that maintains testing integrity throughout development iterations. Your verification and validation planning activities provide the regulatory foundation for demonstrating device safety and effectiveness through systematic testing that addresses all applicable requirements while optimizing development resources and timelines. Well-executed planning reduces testing redundancy, prevents late-stage discoveries of fundamental performance issues, and ensures comprehensive documentation that supports confident regulatory submissions and successful market authorization.