Verification

Verification is a quality assurance process that provides documented evidence that a product, process, or design output meets its specified requirements. In medical device development, verification answers the question: "Did we build the product right?"

Design Verification:

Design verification confirms that design outputs meet design inputs through testing and inspection. This includes:
- Performance testing - Does the device meet functional specifications?
- Safety testing - Does it meet safety requirements?
- Biocompatibility testing - ISO 10993 requirements
- Electrical safety - IEC 60601 compliance
- EMC testing - Electromagnetic compatibility
- Sterility verification - For sterile devices
- Shelf life testing - Stability and packaging integrity

Key Differences: Verification vs Validation:

Verification:
- Confirms specifications are met
- "Did we build the product right?"
- Based on design inputs and outputs
- Uses objective testing and inspection
- Can be done in lab environment
- Typically occurs earlier in development

Validation:
- Confirms user needs are met
- "Did we build the right product?"
- Based on intended use and user requirements
- Uses clinical evaluation and real-world evidence
- Requires actual or simulated use conditions
- Typically occurs later, near product completion

Verification Activities:

1. Test Method Development:
- Define test protocols and procedures
- Establish acceptance criteria
- Identify required equipment and resources
- Qualify test methods

2. Test Execution:
- Follow approved protocols
- Document all test data
- Use calibrated equipment
- Maintain traceability to requirements

3. Data Analysis:
- Statistical evaluation of results
- Compare against acceptance criteria
- Identify out-of-specification results
- Determine pass/fail criteria

Regulatory Requirements:
- FDA 21 CFR 820.30(f) - Design verification required
- EU MDR Annex I - Verification of conformity
- ISO 13485:2016 Clause 7.3.5 - Design verification
- ISO 14971 - Verification of risk controls

Verification Documentation:
- Verification protocols and plans
- Test methods and specifications
- Raw test data and results
- Statistical analysis
- Verification reports
- Traceability matrices linking requirements to tests

Common Verification Standards:
- ISO 10993 - Biocompatibility testing
- IEC 60601-1 - Medical electrical equipment safety
- ISO 14971 - Risk management verification
- ASTM standards for material and mechanical testing

Proper verification ensures that design specifications are met before proceeding to validation and commercial manufacturing.