Design Validation

Design Validation is a critical element of FDA Design Controls (21 CFR 820.30) that confirms a medical device meets user needs and intended uses under actual or simulated use conditions. It answers the question: "Did we build the right thing?"

Design Validation vs Design Verification:
- Validation - Building the RIGHT thing (meets user needs)
- Verification - Building it right (meets design specifications)

Key aspects of Design Validation:

What must be validated:
- Device performs as intended in actual use environment
- Device meets user needs identified in design inputs
- Device is safe and effective for intended users
- Labeling and instructions are adequate
- Device can be used by intended user population

Validation methods:
- Clinical validation - Testing with actual patients in clinical settings
- Simulated use testing - Testing with representative users in controlled environment
- Human factors validation - Usability testing with intended users
- Performance validation - Testing under actual use conditions
- Shelf life validation - Confirming stability over product lifetime

Timing of validation:
- Must occur before design transfer to manufacturing
- Performed on production-equivalent units
- May require multiple validation studies

Documentation requirements:
- Validation protocol (objectives, methods, acceptance criteria)
- Test results and data analysis
- Conclusion that device meets user needs
- Documented in Design History File (DHF)

Regulatory requirements:
- FDA 21 CFR 820.30(g) - Design Validation
- ISO 13485:2016 Section 7.3.6 - Design and Development Validation
- EU MDR - Clinical Evaluation and Performance Testing

When validation must be repeated:
- Design changes affecting safety or effectiveness
- Changes to intended use or user population
- Manufacturing process changes
- New or modified clinical indications

A successful validation demonstrates that your device meets real-world user needs, not just engineering specifications.