Project Overview
This project involved the precision manufacturing of a medical-grade PEEK tray filler component used in a pulse generator fixation device. The component falls under Class II medical devices and required strict dimensional accuracy, cosmetic surface quality, and full unit-level traceability.
Industry: Medical Devices (Class II)
Material: Medical-grade PEEK ZA-500
Manufacturing Process: 5-Axis CNC Milling + Ultrasonic Cleaning
Traceability: Individual laser marking (UDI-ready)
Engineering Definition
The component features thin-wall geometry and complex curved profiles, requiring precise control of deformation, surface finish, and dimensional consistency.
Manufacturing Challenges
- Deformation Control: Thin-wall PEEK structures are prone to stress deformation during machining.
• Surface Quality: Cosmetic medical-grade finish required with no scratches, burrs, or tool marks.
• Full Traceability: 100% unit-level traceability required for regulatory compliance.
Our Manufacturing Solution
- High-precision 5-axis CNC machining minimized re-clamping and improved accuracy.
• Custom anti-deformation fixtures prevented stress during material removal.
• Ultrasonic cleaning ensured medical-grade cleanliness.
• Laser marking enabled full traceability linked to inspection data.
Quality Control & Inspection
All parts were inspected using CMM measurement systems to ensure compliance with medical device manufacturing standards and customer specifications.
Results
- 100% first-pass yield on the initial batch of 500 units.
• All critical dimensions met drawing tolerances.
• Delivery completed ahead of schedule.
• Parts were immediately approved for assembly.
