Merancang, Peranti Perubatan Prototaip dan Pembuatan

Prototaip peranti perubatan dan pembuatan

(4967 Kajian Pelanggan)

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

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.

Why Expertise Matters in Medical Devices

Medical parts face stringent requirements: biokompatibiliti, 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 & Perkhidmatan

Perkhidmatan Manfaat Toleransi tipikal
SLA & PolyJet 3D Printing High detail, permukaan licin ± 0.1 mm
SLS Nylon Prototyping Tahan lama, bahagian berfungsi ± 0.2 mm
Pemesinan CNC (Logam & Plastik) Production-grade accuracy ± 0.05 mm
Urethane Casting & Soft Tooling Low-volume, rapid turnaround ± 0.2 mm
Penamat permukaan & Sterilization Prep Medical-grade polish, Passivation T/A

Material Selection & Biokeserasian

We offer a range of ISO 10993-certified materials:

  • Medical-grade ABS & PC-ISO
  • Mengintip & 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 & Maklum balas DFM
  2. Prototype fabrication (SLA, SLS, CNC)
  3. Pemeriksaan dimensi & functional testing
  4. Low-volume tooling or pilot production
  5. Batch manufacturing & ISO 13485 documentation

Key Applications

Permohonan Contoh
Surgical Instruments Mengendalikan, 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 Pengurusan Kualiti Bersertifikat
  • FDA design control guidance
  • Full traceability of materials and batches
  • Sterilization validation support
Medical_Device_Prototyping

Medical_Device_Prototyping

Mengapa Memilih Langhe Casting?

  • 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

Soalan yang sering ditanya

Q1: Which sterilization methods do you support?

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

S2: Can you produce CE-marked prototypes?

Ya, 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

Hubungi kami

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

E -mel: [email protected]
Telefon: +86 18838939163

Perkhidmatan

Perkhidmatan yang berkaitan