Glossary Term
Assay Development
Definition
Assay Development refers to the process of designing, optimizing, and validating a test or method for detecting, quantifying, or analyzing biological or chemical components. In the MedTech industry, assays are integral to diagnostics, drug discovery, and quality control, enabling the measurement of biomarkers, pathogens, or therapeutic efficacy.
Relevance to the MedTech Industry
Assay Development is essential for creating diagnostic tests and analytical tools that ensure accurate detection and quantification of clinically relevant targets. It supports innovation in diagnostics, personalized medicine, and the evaluation of medical device safety and performance.
Additional Information & Related Terms
Analytical Validation Confirms the assay's accuracy, precision, and reliability for its intended purpose.
Clinical Validation Demonstrates that the assay produces clinically meaningful results.
Biomarkers Targets measured in assay development for diagnostics or therapy monitoring.
ISO 13485 Governs the quality management systems for assay development in diagnostic devices.