Ngrancang, Pabrik Prototyping lan Manufaktur Piranti Medis

Prototyping Piranti Medis lan Manufaktur

(4967 Review pelanggan)

  • Produk kelas produksi
  • ISO 9001:2015 disertifikasi
  • 24/7 dhukungan engineering

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: Biokunikasi, 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 & Layanan

Layanan Mupangat Toleransi khas
SLA & PolyJet 3D Printing High detail, Lumahing lancar ± 0,1 mm
SLS Nylon Prototyping Tahan lama, Bagéan Fungsional ± 0,2 mm
Machining CNC (Metals & Plastik) Production-grade accuracy ± 0,05 mm
Urethane Casting & Soft Tooling Low-volume, rapid turnaround ± 0,2 mm
Lumahing finishing & Sterilization Prep Medical-grade polish, Passivasi N/A

Material Selection & Biokompatibilitas

We offer a range of ISO 10993-certified materials:

  • Medical-grade ABS & PC-ISO
  • PEEK & Ultem kanggo aplikasi suhu dhuwur
  • Stainless Steel 316L lan Titanium Ti-6Al-4V
  • Elastomer (Tpu) kanggo asu laut lan gaskets
medical-peralatan

medical-peralatan

Alur Kerja End-to-End

  1. Review desain & Umpan Balik DFM
  2. Fabrikasi prototipe (SLA, Sls, Cnc)
  3. Pemeriksa Dimensional & testing fungsional
  4. Perkakas volume rendah utawa produksi pilot
  5. Produksi batch & ISO 13485 dokumentasi

Aplikasi Kunci

Aplikasi Tuladha
Instrumen Bedhah Ngalahake, guide jig, pengeboran bit
Piranti Implantable Piring balung, komponen gabungan
Omah Diagnostik Sensor, maca genggam
Model khusus pasien Replika anatomi kanggo perencanaan pra-bedah

Kepatuhan Regulasi & Kualitas

Proses kita selaras karo:

  • ISO 13485 Manajemen Kualitas sing Disertifikasi
  • pedoman kontrol desain FDA
  • Telusuri lengkap bahan lan batch
  • Dhukungan validasi sterilisasi
Medical_Device_Prototyping

Medical_Device_Prototyping

Napa milih Langhe Casting?

  • Keahlian multi-disiplin ing prototyping medis
  • Pengulangan cepet kanggo validasi klinis lan desain
  • Bahan biokompatibel lan tes sing ketat
  • Transisi lancar menyang produksi volume
  • Dokumentasi lengkap kanggo pengajuan peraturan
Prototyping Piranti Medis

Prototyping Piranti Medis

Pitakon sing asring takon

Q1: Cara sterilisasi apa sing sampeyan dukung?

We nyiapake bagean kanggo EO, gamma, lan sterilisasi autoklaf kaya sing dibutuhake.

Q2: Apa sampeyan bisa ngasilake prototipe sing ditandhani CE?

Ya, kita mbantu label lan dokumentasi CE lan FDA kanggo prototipe.

Q3: Apa wektu timbal khas sampeyan?

Prototipe ing 3-7 dina; produksi pilot ing 2-4 minggu.

Layanan Mesin CNC kanggo Industri Medis

Layanan Mesin CNC kanggo Industri Medis

Hubungi kita

Nyepetake program piranti medis kanthi Langhe Casting. Tekan metu kanggo kutipan, konsultasi teknis, lan produksi ISO-compliant.

Email: [email protected]
Telpon: +86 18838939163

Layanan

Layanan sing gegandhengan