top of page
Glossary Term
First Article Inspection (FAI)
Definition
First Article Inspection (FAI) is a quality assurance process in which the first unit produced in a manufacturing run is thoroughly inspected and tested to verify that it meets all specified requirements, including design, material, and dimensional tolerances. This process ensures that production processes are set up correctly and capable of producing consistent, compliant products.
Relevance to the MedTech Industry
FAI is critical in the MedTech industry to ensure the integrity, functionality, and safety of medical devices. By validating manufacturing processes at the start of production, FAI minimizes risks of non-conformance and ensures devices meet stringent regulatory and quality standards.
Additional Information & Related Terms
bottom of page