Design Verification

Design Verification is a critical element of FDA Design Controls (21 CFR 820.30) that confirms design outputs meet the design inputs specified at the beginning of development. It answers the question: "Did we build it right?"

Design Verification vs Design Validation:
- Verification - Building it RIGHT (outputs meet inputs)
- Validation - Building the right thing (device meets user needs)

Purpose of Design Verification:
- Confirms design outputs satisfy design inputs
- Provides objective evidence through testing
- Ensures specifications are met before validation
- Identifies design flaws before manufacturing

Common verification activities:

1. Performance Testing
- Electrical safety testing
- Mechanical strength testing
- Software functionality testing
- Biocompatibility testing

2. Environmental Testing
- Temperature/humidity cycling
- Shock and vibration testing
- Transportation simulation
- Accelerated aging

3. Standards Compliance
- IEC 60601 electrical safety
- ISO 10993 biocompatibility
- ISO 14971 risk management
- Product-specific standards

4. Software Verification
- Unit testing
- Integration testing
- Code reviews
- Requirements traceability

Verification documentation:
- Verification Protocol - Test objectives, methods, acceptance criteria
- Test Reports - Detailed results and data analysis
- Traceability Matrix - Links inputs to outputs to verification tests
- Conclusion - Statement that outputs meet inputs
- Stored in Design History File (DHF)

When verification is required:
- Before design validation
- After design changes
- Before design transfer to manufacturing
- As part of risk mitigation verification

Regulatory requirements:
- FDA 21 CFR 820.30(f) - Design Verification
- ISO 13485:2016 Section 7.3.5 - Design and Development Verification
- EU MDR Technical Documentation requirements

Key principle: Verification uses objective, measurable testing to prove that engineering specifications were met. If verification fails, the design must be modified before proceeding to validation.