Glossary Term
Analytical Validation
Definition
Analytical Validation is the process of demonstrating that a specific test, method, or assay produces reliable, consistent, and accurate results for its intended purpose. In the MedTech industry, this process is critical for validating diagnostic devices, companion diagnostics, and laboratory assays, ensuring they meet regulatory and clinical standards.
Relevance to the MedTech Industry
Analytical Validation ensures that diagnostic tests and devices provide accurate and reproducible results, which is essential for clinical decision-making, regulatory compliance, and patient safety. This process forms the foundation for demonstrating the reliability of diagnostic methods and supporting their integration into clinical workflows.
Additional Information & Related Terms
Clinical Validation Demonstrates that a device's performance aligns with its intended clinical use.
Companion Diagnostics (CDx) Often require rigorous Analytical Validation to support targeted therapies.
ISO 13485 Ensures quality management processes include validation of diagnostic methods.
Sensitivity and Specificity Key metrics evaluated during Analytical Validation.