Тарҳрезӣ, Прототипҳо ва дастгоҳҳои тиббии истеҳсолӣ

Прототипҳои тибби тиббӣ ва истеҳсолот

(4967 Шарҳи муштариён)

  • Маҳсулоти дараҷаи истеҳсолӣ
  • Iso 9001:2015 шаҳодатнома
  • 24/7 дастгирии муҳандисӣ

Ланге кастинг 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: БИЯБОМА, 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 & Хизматрасонӣ

Хизматрасонӣ Суд Таҳаммулпазирии маъмулӣ
КВА & PolyJet 3D Printing High detail, сатҳи ҳамвор ± 0.1 мм
SLS Nylon Prototyping Мустаҳкам, Қисмҳои функсионалӣ ± 0.2 мм
CNC коркард (Метал & Пластикӣ) Production-grade accuracy ± 0.05 мм
Urethane Casting & Soft Tooling Low-volume, rapid turnaround ± 0.2 мм
Сатҳи рӯизаминӣ & Sterilization Prep Medical-grade polish, мафҳум Н / а

Material Selection & Мутобиқати биологӣ

We offer a range of ISO 10993-certified materials:

  • Medical-grade ABS & PC-ISO
  • Ғо & 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 фикру мулоҳизоти DFM
  2. Prototype fabrication (КВА, Сӯрох, Cnc)
  3. Бозрасии андоза & functional testing
  4. Low-volume tooling or pilot production
  5. Batch manufacturing & Iso 13485 documentation

Key Applications

Изҳорот Намунаҳо
Surgical Instruments Дастак, 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 Идоракунии сифат тасдиқшуда
  • FDA design control guidance
  • Full traceability of materials and batches
  • Sterilization validation support
Medical_Device_Prototyping

Medical_Device_Prototyping

Чаро лангро интихоб кунед?

  • 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

Саволҳои зуд-зуд додашуда

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?

Ҳа, 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

Бо мо тамос гиред

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

Имейл: [email protected]
Телефон: +86 18838939163

Хизматрасонӣ

Хизматрасонии марбут