Project Overview
Detailed look at our work with a medical device manufacturer
Project Summary
A medical device manufacturer needed implant components made from biocompatible titanium alloy with ultra-precision surface finish of Ra 0.2μm. These components were critical to patient safety and required the highest level of quality control and compliance.
Challenge
The medical device manufacturer required implant components with biocompatible titanium alloy and ultra-precision surface finish of Ra 0.2μm. These components were critical to patient safety and required the highest level of quality control and compliance.
Key challenges included:
- Biocompatible titanium alloy machining with strict contamination control
- Ultra-precision surface finish requirements (Ra 0.2μm)
- Stringent ISO 13485 compliance requirements
- Full traceability and documentation for each component
- Zero-defect quality standards for patient safety
Solution
We implemented our ISO 13485 compliant processes with specialized cleaning and quality inspection protocols to meet the stringent requirements for medical device manufacturing.
Our approach included:
- Dedicated clean room environment for medical component production
- Specialized tooling and cutting parameters for titanium machining
- Advanced surface finishing techniques to achieve Ra 0.2μm
- 100% inspection with CMM and surface roughness measurement
- Complete documentation and traceability for each component
Results
We successfully delivered over 5,000 components with 100% quality compliance, achieving the required Ra 0.2μm surface finish and meeting all ISO 13485 requirements.
Key outcomes:
- Ra 0.2μm surface finish achieved on all components
- 100% quality compliance with zero defects
- Full documentation and traceability maintained
- Client received regulatory approval for their device
- Expanded partnership for additional medical components