Langhe Casting delivers comprehensive medical device prototyping and manufacturing. We combine rapid additive techniques, precision CNC machining, and biocompatible materials to accelerate product development and ensure regulatory compliance.
Medical parts face stringent requirements: biocompatibility, sterilization, and mechanical reliability. Our team applies ISO 13485-aligned processes to guarantee each prototype and produced component meets clinical and regulatory standards.
Source Custom Parts for the Medical Industry
| Service | Benefit | Typical Tolerance |
|---|---|---|
| SLA & PolyJet 3D Printing | High detail, smooth surfaces | ±0.1 mm |
| SLS Nylon Prototyping | Durable, functional parts | ±0.2 mm |
| CNC Machining (Metals & Plastics) | Production-grade accuracy | ±0.05 mm |
| Urethane Casting & Soft Tooling | Low-volume, rapid turnaround | ±0.2 mm |
| Surface Finishing & Sterilization Prep | Medical-grade polish, passivation | N/A |
We offer a range of ISO 10993-certified materials:
medical-equipments
| Application | Examples |
|---|---|
| Surgical Instruments | Handles, guide jigs, drill bits |
| Implantable Devices | Bone plates, joint components |
| Diagnostic Housings | Sensors, handheld readers |
| Patient-specific Models | Anatomical replicas for pre-surgical planning |
Our processes align with:
Medical_Device_Prototyping
Medical Device Prototyping
We prepare parts for EO, gamma, and autoclave sterilization as required.
Yes, we assist with CE and FDA labeling and documentation for prototypes.
Prototypes in 3–7 days; pilot production in 2–4 weeks.
CNC Machining Service for Medical Industry
Accelerate your medical device program with Langhe Casting. Reach out for a quote, technical consultation, and ISO-compliant production.
Email: [email protected]
Phone: +86 18838939163
