Verification and Validation Stage Checklists
Verification And Validation Report
Summarize comprehensive testing activities proving device safety effectiveness and market readiness.
Summary
The Verification and Validation Report provides a comprehensive summary of all verification and validation activities conducted during your medical device development, demonstrating that your device meets both design requirements and user needs.Why is Verification and Validation Report important?
The Verification and Validation Report is essential for demonstrating that your medical device development process has been completed successfully and that your device is safe and effective for its intended use. This document provides regulatory authorities with evidence that you have systematically tested your device to ensure it meets all design requirements (verification) and fulfills user needs and intended use (validation). It serves as the culmination of your design control process, proving that your device performs as intended and is ready for market release. Without comprehensive verification and validation documentation, you cannot demonstrate that your device is safe, effective, and compliant with regulatory requirements.Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation) and Design Controls:
- Design verification must demonstrate that design outputs meet design inputs (820.30(f))
- Design validation must demonstrate that devices meet user needs and intended use (820.30(g))
- Design transfer must ensure design is correctly translated to production (820.30(h))
- Design history file must contain all verification and validation records (820.30(j))
Special attention required for:
- Class II and III devices requiring extensive verification and validation documentation
- Software medical devices requiring software lifecycle verification and validation
- Combination products requiring coordination between device and drug V&V activities
- 510(k) submissions requiring substantial equivalence demonstration through V&V
Guide
Your Verification and Validation Report must provide a comprehensive overview of all testing activities conducted to demonstrate that your device meets requirements and user needs. This document should synthesize results from all verification and validation activities into a clear conclusion about device readiness.Verification Activities Summary
Document all verification activities that demonstrate your design outputs meet your design inputs. This includes system testing, subsystem testing, software testing, hardware testing, and any other technical verification activities. Reference specific test protocols and test reports that provide evidence of requirement compliance. Summarize pass/fail results and document how any failures were addressed through design changes or additional testing.Validation Activities Summary
Document all validation activities that demonstrate your device meets user needs and intended use. This includes usability testing, clinical validation, performance validation, and any other user-focused validation activities. Reference specific validation protocols and validation reports that provide evidence of user need fulfillment. Summarize validation outcomes and document how any issues were addressed.Risk Management Integration
Demonstrate how your verification and validation activities address the risks identified in your risk assessment. Show that risk controls have been verified to be effective and that residual risks are acceptable. Reference your Risk Management Report and Traceability Matrix to show complete integration between risk management and V&V activities.Design Transfer Verification
Document verification that your design has been correctly transferred to production. This includes verification of manufacturing processes, quality controls, and any production-specific testing. Demonstrate that the production version of your device maintains the same performance characteristics as the design version used in verification and validation testing.Overall Conclusion
Provide a clear conclusion about whether your device is ready for market release based on all verification and validation evidence. Address any outstanding issues or limitations and document how they will be managed. This conclusion should be supported by objective evidence from all V&V activities.Example
Scenario: You develop a wearable heart rate monitoring device for fitness tracking. Your verification and validation activities include electrical safety testing, software verification, usability testing with target users, and clinical validation of heart rate accuracy. All testing demonstrates that the device meets requirements and user needs, with only minor usability improvements identified for future versions.Verification and Validation Report
ID: VVR-001 1. Executive Summary This Verification and Validation Report summarizes all verification and validation activities conducted for the FitHeart Wearable Monitor during the design and development phase. All verification activities have demonstrated that design outputs meet design inputs, and all validation activities have confirmed that the device meets user needs and intended use. The device is ready for market release. 2. Verification Activities Summary 2.1 System Verification System-level verification was conducted according to the System Test Plan (STP-001) and documented in the System Test Report (STR-001). All 45 system-level test cases passed, demonstrating compliance with system requirements.- Electrical Safety Testing: Passed all IEC 60601-1 requirements for electrical safety
- EMC Testing: Passed all IEC 60601-1-2 requirements for electromagnetic compatibility
- Software Verification: All 127 software test cases passed, with 2 minor anomalies documented in List of Known Anomalies
- Performance Testing: Heart rate accuracy within ±2 BPM across all test conditions
- Heart Rate Sensor Module: Verified accuracy and response time per SSR-001 through SSR-005
- Wireless Communication Module: Verified data transmission reliability per SSR-006 through SSR-008
- Battery Management System: Verified power consumption and charging per SSR-009 through SSR-012
- User Interface Module: Verified display functionality and user controls per SSR-013 through SSR-015
- Task Success Rate: 98% across all critical tasks
- User Satisfaction: Average score of 4.6/5.0
- Use Errors: No use errors that could lead to patient harm identified
- Minor Improvements: 3 minor usability improvements identified for future software updates
- Heart Rate Accuracy: Mean absolute error of 1.2 BPM (within specification of ±2 BPM)
- Correlation: R² = 0.98 correlation with reference standard
- Clinical Performance: No clinically significant measurement errors identified
- Risk Controls Verified: All 12 implemented risk controls verified effective through testing
- Residual Risk Assessment: All residual risks confirmed acceptable through validation activities
- Risk Traceability: Complete traceability demonstrated in Traceability Matrix (TM-001)
- Production Verification: First 10 production units tested and confirmed equivalent to design units
- Manufacturing Process Validation: All manufacturing processes validated per Manufacturing Validation Report
- Quality Control Verification: Production quality controls verified effective
- Battery Life Display: Minor improvement needed in battery life estimation algorithm (planned for v1.1)
- Bluetooth Connectivity: Occasional connection delays in high-interference environments (acceptable per risk assessment)
- User Manual Clarity: Two sections identified for improvement in next revision
Q&A
What's the difference between verification and validation?
What's the difference between verification and validation?
Verification demonstrates that your design outputs meet your design inputs (requirements), while validation demonstrates that your device meets user needs and intended use. Verification asks “did we build it right?” while validation asks “did we build the right thing?”
How should software testing be documented in the V&V report?
How should software testing be documented in the V&V report?
System testing serves as both verification and validation. Document test plan execution, pass/fail status with justifications, and how any failures were addressed. Reference specific test reports and ensure traceability to requirements.
What should I do if some verification or validation activities fail?
What should I do if some verification or validation activities fail?
Document all failures, analyze root causes, implement corrective actions (design changes, additional testing, etc.), and re-test to demonstrate compliance. All failures must be resolved before concluding that V&V is complete.
How detailed should my V&V report be?
How detailed should my V&V report be?
The report should provide sufficient detail to demonstrate completeness without repeating all test data. Reference specific test reports and protocols, summarize key results, and provide clear conclusions about device readiness.
Can I use the same testing for both verification and validation?
Can I use the same testing for both verification and validation?
Some testing activities can serve both purposes, but you must clearly identify which requirements are being verified and which user needs are being validated. System testing often serves both functions when properly designed.
What should I include about design transfer in the V&V report?
What should I include about design transfer in the V&V report?
Document verification that production units perform equivalently to design units used in V&V testing. Include manufacturing process validation results and confirmation that quality controls maintain design performance.