First Article Inspection
At MedFab, quality is paramount. As a high-precision manufacturer of medical, aerospace, and high-tech components, we adhere to stringent industry standards to ensure every part meets exact specifications. One of the critical steps in our quality assurance process is First Article Inspection (FAI)—a meticulous verification process that validates our manufacturing capabilities before full-scale production begins.
FAI the MedFab Way
FAI is a comprehensive evaluation of the first produced component in a manufacturing run. This process verifies that the initial part meets all design, material, and dimensional requirements. At MedFab, we conduct FAI according to AS9102 standards, ensuring a detailed and structured review that minimizes errors and enhances repeatability.
MedFab’s FAI process follows a systematic approach to guarantee consistency and precision in medical, aerospace, and high-tech manufacturing:
- Material and Design Verification – We confirm that the materials used comply with the customer’s specifications and regulatory standards, ensuring safety and biocompatibility for medical applications.
- Dimensional Inspection – Using advanced metrology equipment, we measure critical dimensions to verify compliance with engineering drawings and tolerances.
- Process Validation – We analyze machining, micro-manufacturing, and finishing techniques to ensure production consistency.
- Documentation and Reporting – We compile a complete FAI report, including measurement data, material certifications, and compliance checklists, providing full transparency and traceability.
FAI for Medical Manufacturing
In the medical industry, precision is non-negotiable. A defective or non-conforming component can lead to performance issues, regulatory challenges, or patient safety concerns. FAI ensures:
- Regulatory Compliance – We align with ISO 13485:2016 requirements, supporting medical device manufacturers in meeting FDA and EU MDR regulations.
- Defect Prevention – We prevent costly rework and delays by identifying discrepancies early.
- Consistency in Production – FAI establishes a benchmark for all subsequent manufacturing runs, allowing us to verify reliability every time.
Trust MedFab for Unmatched Quality Assurance
MedFab integrates First Article Inspection as a fundamental step in our precision manufacturing process. Our commitment to quality, compliance, and meticulous verification guarantees that every medical, aerospace, or high-tech component we produce meets the highest industry standards.
Entrust your medical, aerospace, and high-tech parts manufacturing to MedFab for the most meticulous, precision-driven solutions.
Contact MedFab today to learn more about our FAI process and quality assurance expertise.