Our end-to-end custom injection molding service is engineered for the precise and demanding needs of the medical industry. We specialize in the manufacturing of high-performance dental handpieces and other critical medical components. From initial design for manufacturability to rigorous post-processing and validation, we ensure every part meets the highest standards of quality, reliability, and compliance.
Key Features and Benefits
ISO 13485 Certified Manufacturing ensuring compliance for medical device production
Biocompatible Material Expertise with a wide selection of USP Class VI and ISO 10993 certified resins
Class 10000 Cleanroom Production for critical components to avoid particulate contamination
Full Validation Support including IQ OQ PQ protocols and detailed material certifications
High-Precision Micro-Molding Capabilities for intricate dental handpiece components
Attribute Category | Specification Details |
---|---|
Service Type | Custom Injection Molding Full Service Turnkey Solution |
Industry Focus | Medical Devices Dental Equipment Healthcare |
Key Materials | PEEK PC PP Medical PP ABS |
Material Standards | ISO 10993 USP Class VI FDA Compliant FR Grades |
Certifications | ISO 134851 Quality Management System ISO 9001 |
Tolerances | ± 0.05 |
Mold Capacity | Up to 500 Tons Clamping Force |
Secondary Operations | Ultrasonic Welding Precision Assembly Pad Printing Laser Marking |
Quality Control | CMM Measurement Vision Systems Full Part Traceability |
Packaging | Cleanroom ESD Safe Foam Medical Grade Sterilization Pouches |