Design, prototyper och tillverkning av medicinsk utrustning

Prototyper och tillverkning av medicinsk utrustning

(4967 Kundrecension)

  • Produktionsklassade produkter
  • Iso 9001:2015 auktoriserad
  • 24/7 ingenjörsstöd

Langhe -gjutning 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.

Why Expertise Matters in Medical Devices

Medical parts face stringent requirements: biokompatibilitet, 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

Source Custom Parts for the Medical Industry

Core Technologies & Tjänster

Service Förmån Typisk tolerans
Sla & PolyJet 3D Printing High detail, släta ytor ± 0,1 mm
SLS Nylon Prototyping Hållbar, funktionella delar ± 0,2 mm
CNC -bearbetning (Metaller & Plast) Production-grade accuracy ± 0,05 mm
Urethane Casting & Soft Tooling Low-volume, rapid turnaround ± 0,2 mm
Ytbehandling & Sterilization Prep Medical-grade polish, passivering N/a

Material Selection & Biokompatibilitet

We offer a range of ISO 10993-certified materials:

  • Medical-grade ABS & PC-ISO
  • TITT & Ultem for high-temp applications
  • Stainless Steel 316L and Titanium Ti-6Al-4V
  • Elastomers (Tpu) for seals and gaskets
medical-equipments

medical-equipments

End-to-End Workflow

  1. Design review & DFM -feedback
  2. Prototype fabrication (Sla, Sls, Cnc)
  3. Dimensionell inspektion & functional testing
  4. Low-volume tooling or pilot production
  5. Batch manufacturing & Iso 13485 documentation

Key Applications

Ansökan Exempel
Surgical Instruments Handtag, guide jigs, drill bits
Implantable Devices Bone plates, joint components
Diagnostic Housings Sensors, handheld readers
Patient-specific Models Anatomical replicas for pre-surgical planning

Regulatory Compliance & Quality

Our processes align with:

  • Iso 13485 Certifierad kvalitetshantering
  • FDA design control guidance
  • Full traceability of materials and batches
  • Sterilization validation support
Medical_Device_Prototyping

Medical_Device_Prototyping

Varför välja Langhe -gjutning?

  • Multi-discipline expertise in medical prototyping
  • Fast iterations for clinical and design validation
  • Biocompatible materials and rigorous testing
  • Seamless transition to volume manufacturing
  • Comprehensive documentation for regulatory submissions
Medical Device Prototyping

Medical Device Prototyping

Vanliga frågor

F1: Which sterilization methods do you support?

We prepare parts for EO, gamma, and autoclave sterilization as required.

F2: Can you produce CE-marked prototypes?

Ja, we assist with CE and FDA labeling and documentation for prototypes.

F3: What is your typical lead time?

Prototypes in 3–7 days; pilot production in 2–4 weeks.

CNC Machining Service for Medical Industry

CNC Machining Service for Medical Industry

Kontakta oss

Accelerate your medical device program with Langhe -gjutning. Reach out for a quote, technical consultation, and ISO-compliant production.

E-post: yttre [email protected]
Telefon: +86 18838939163

Tjänster

Relaterade tjänster