Full Material Traceability
Complete documentation and revision control systems ensure 100% traceability from raw stock to finished medical part.
Quality Assurance & Compliance
Uncompromising Quality at Every Step.
Dedicated medical-device quality management — every component manufactured with rigorous traceability, validated processes, and inspection in a controlled environment.
ISO 13485:2016
Medical Device Certified
Dedicated medical-device quality management system covering design, manufacturing, and post-production controls — with certified ISO 13485 lead auditors on staff.
ISO 9001:2015
Quality Management Systems
Foundational quality management certification ensuring consistency, continuous improvement, and customer focus across every program.
Advanced Inspection Equipment
Measuring to a higher standard.
Automated CMMs
Two fully automated Mitutoyo Crysta-Apex Coordinate Measuring Machines, capable of inspecting directly to blueprints and/or solid CAD models.
Optical Comparators
Mitutoyo Optical Comparator for precise non-contact measurement of complex profiles and micro-features.
Controlled Environment
Fully environmentally controlled inspection room ensures absolute dimensional stability when measuring critical medical components.
Rigorous Quality Processes
Documentation, validation, traceability.
Validated Production
Documented validation of all processes prior to production, supported by comprehensive operator training and work instructions.
First Article Inspection
Documented FAI protocols verify that every engineering, design, and specification requirement is met before serial production begins.
Auditing a new medical-device supplier?
Request our quality manual, FAI samples, and certification documentation.