Validation

Validation is a quality assurance process that provides documented evidence that a product, process, or system consistently meets predetermined specifications and user requirements for its intended use. In medical device development, validation answers the question: "Are we building the right product?"

Types of Validation:

Design Validation - Demonstrates that the finished device meets defined user needs and intended uses under actual or simulated use conditions. This includes:
- Clinical evaluation and testing
- Usability validation
- Performance testing in real-world scenarios
- Validation of risk controls effectiveness

Process Validation - Establishes that manufacturing processes consistently produce devices meeting specifications. The three stages are:
- Stage 1: Process Design - Define process requirements
- Stage 2: Process Qualification - IQ (Installation), OQ (Operational), PQ (Performance Qualification)
- Stage 3: Continued Process Verification - Ongoing monitoring

Software Validation - Confirms software performs its intended functions correctly and reliably. Required for:
- Software as a Medical Device (SaMD)
- Embedded software in devices
- Manufacturing process software
- Quality management system software

Key Differences: Validation vs Verification:
- Verification asks "Did we build the product right?" (meets specifications)
- Validation asks "Did we build the right product?" (meets user needs)
- Verification uses testing and inspection
- Validation uses clinical evaluation and real-world evidence

Regulatory Requirements:
- FDA - 21 CFR 820.75 requires process validation
- EU MDR - Annex I requires clinical evaluation
- ISO 13485 - Clause 7.3.6 and 7.5.6 specify validation requirements
- IEC 62304 - Software lifecycle validation

Validation Documentation:
- Validation protocols and plans
- Test methods and acceptance criteria
- Raw data and results
- Statistical analysis
- Validation reports and conclusions
- Deviations and corrective actions

Proper validation ensures product safety, effectiveness, and regulatory compliance throughout the device lifecycle.