Designing, pwototip ak fabrikasyon aparèy medikal

Pwototip ak fabrikasyon aparèy medikal

(4967 Revizyon Kliyan)

  • Production-grade products
  • ISO 9001:2015 sètifye
  • 24/7 engineering support

Langhe Distribisyon 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: 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

Source Custom Parts for the Medical Industry

Core Technologies & Sèvis

Lanmès Benefis Tolerans tipik
SLA & PolyJet 3D Printing High detail, Sifas lis ± 0.1 mm
SLS Nylon Prototyping Dirab, Pati fonksyonèl ± 0.2 mm
CNC D ' (Metal & Plastik) Production-grade accuracy ± 0.05 mm
Urethane Casting & Soft Tooling Low-volume, rapid turnaround ± 0.2 mm
Sifas fini & Sterilization Prep Medical-grade polish, pasivasyon N/A

Material Selection & Biokonpatibilite

We offer a range of ISO 10993-certified materials:

  • Medical-grade ABS & PC-ISO
  • SAP & 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 fidbak
  2. Prototype fabrication (SLA, Sl, CNC)
  3. Enspeksyon dimansyon & functional testing
  4. Low-volume tooling or pilot production
  5. Batch manufacturing & ISO 13485 documentation

Key Applications

Aplikasyon Egzanp
Surgical Instruments Manch, 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 Jesyon bon jan kalite sètifye
  • FDA design control guidance
  • Full traceability of materials and batches
  • Sterilization validation support
Medical_Device_Prototyping

Medical_Device_Prototyping

Poukisa Chwazi Langhe Distribisyon?

  • 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

Kesyon yo poze souvan

Q1: Which sterilization methods do you support?

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

Q2: Can you produce CE-marked prototypes?

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

Q3: 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

Kontakte nou

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

Imèl: [email protected]
Telefòn: +86 18838939163

Sèvis

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