Custom Injection Molded Medical Device Parts
Product Summary
Our custom injection molded medical device parts are produced with high precision and strict quality control. Materials are selected for biocompatibility and regulatory compliance (FDA 21 CFR 177.2600 for silicone, RoHS). 100% dimensional and visual inspection ensures defect-free parts.
Key Selling Points
- High Precision Molding: Tight tolerances for critical medical device assembly.
- FDA Compliant Materials: SGS certified FDA food contact material test (21 CFR 177.2600) for silicone.
- RoHS Compliance: SGS EU RoHS test report available for materials.
- Clean and Defect-Free Surfaces: Suitable for clean-use medical environments.
- 100% Quality Inspection: Dimensional measurement and visual check for every part.
Technical Specifications
| Parameter | Details |
|---|
| Production Process | Plastic injection molding |
| Part Size | Customized |
| Production Volume | Prototype to mass production |
| Tolerance | Per customer specifications (tight tolerances) |
| Materials | ABS, PP, PC, PC+ABS, TPE, Acrylic, Silicone |
| Surface Finish | Texture, polishing, painting, printing |
| Standards | ISO 9001:2015, RoHS, FDA (on selected materials) |
Models and Options
Model DTG-CIMP-001. Options include overmolding, insert molding, and custom packaging for cleanroom compatibility.
Materials and Structure
Engineering plastics with FDA compliance where needed (e.g., silicone for seals). Structures can include thin walls, precision holes, and smooth surfaces.
Applications
- Medical device housings
- Healthcare product components
- Diagnostic equipment parts
- Surgical instrument handles
Customization
Full customization from mold design to production. Material selection guided by regulatory requirements. DFM support for design optimization.
FAQ
1. Do you have ISO 13485 certification?
We are ISO 9001:2015 certified. We follow strict quality management and can support medical device manufacturing requirements.
2. Can you provide FDA-compliant materials?
Yes, we have SGS test reports for FDA food contact compliance for silicone materials.
3. What is the surface finish capability?
We offer surface finishes including texture, polishing, and painting to meet aesthetic and functional needs.
4. Do you perform 100% inspection?
Yes, for medical parts we can implement 100% dimensional and visual inspection.
5. What is the typical lead time for prototypes?
Prototype tooling can be completed in 2-3 weeks, production tooling in 4-6 weeks.
6. Can you handle cleanroom production?
We can adapt processes to meet cleanroom requirements; please discuss specifics.
7. What file formats do you require?
STEP, IGES, or STL files are preferred.
8. How do you ensure material traceability?
We maintain batch records and can provide material certificates upon request.
Inquiry Information
Contact: Cindy Li, Email: sales@m-dtg.com, WhatsApp: +86 133-1340-7440
