Process Validations
Our process validation capabilities are built to support the stringent regulatory demands of medical device manufacturing. C-Axis follows robust IQ, OQ, and PQ protocols to verify that each process is stable, repeatable, and fully aligned with customer and industry standards. This disciplined approach reduces risk and ensures confidence during scale-up and commercialization.
C-Axis follows a structured and disciplined validation framework that ensures every process is capable, compliant, and production-ready. Our engineering, quality, and manufacturing teams work collaboratively to plan, execute, and document each validation step, delivering confidence and traceability for customers preparing components for FDA submissions or large-scale manufacturing. With advanced metrology systems, proven methodologies, and deep medical device expertise, we help reduce risk and ensure smooth transitions into validated production.
Advantages:
- Full IQ, OQ, and PQ support for machining, laser processing, finishing, and assembly
- Robust documentation aligned with FDA, ISO 13485, and customer-specific requirements
- Cross-functional engineering and quality collaboration to ensure process stability
- Advanced metrology and inspection systems for precise measurement and verification
- Reduced scale-up risk through controlled, repeatable, and well-characterized processes
- Clear traceability and audit readiness for regulatory compliance and customer quality reviews
- Support for implantable, surgical, and minimally invasive medical device components
Examples of Process Validation Work
C-Axis provides process validations for a wide range of machining, laser, EDM, and finishing operations used in the production of implantable, surgical, and minimally invasive medical devices. Our validation activities ensure every critical process is stable, repeatable, and capable of meeting both customer specifications and regulatory expectations.
- Machining validation for Swiss turning, multi-axis CNC milling, and mill-turn operations
- Laser process validations including cutting, welding, drilling, and marking
- EDM process validations for wire EDM and complex profile generation
- Metal finishing validations such as electropolishing, passivation, and bead blasting
- Critical dimensional and geometric validation using advanced metrology and inspection systems
- Fixture and tooling qualification to ensure consistent part holding and repeatable setups
- Assembly and sub-component validation for surgical and mechanical device components
- Process capability studies (Cp, Cpk) to confirm statistical performance and long-term stability
Other Capabilities
Precision Machining
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We look at C-Axis 360 as an opportunity for our customers to save weeks of development time by having their project team come into our facility. Here they are assigned a C-Axis team (an Engineer, Technician, and Machinist) to work with to complete multiple iterations in one sitting, helping to improve the R&D timeline. Instead of doing things in series, our customers can do multiple potential design iterations in parallel and save six or seven weeks in their NPD cycles. — Olson