Дизајнирање, израду прототипа и производњу медицинских уређаја

Израда прототипа и производња медицинских уређаја

(4967 Преглед купца)

  • Производи производног квалитета
  • ИСО 9001:2015 сертификован
  • 24/7 инжењерска подршка

Лангхе ливење 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: биокомпатибилност, 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 & Услуге

Служба Корист Типична толеранција
Сладолијармент & PolyJet 3D Printing High detail, глатке површине ± 0,1 мм
SLS Nylon Prototyping Издржљив, Функционални делови ± 0,2 мм
ЦНЦ обрада (Метали & Пластика) Production-grade accuracy ± 0,05 мм
Urethane Casting & Soft Tooling Low-volume, rapid turnaround ± 0,2 мм
Дорада површине & Sterilization Prep Medical-grade polish, пасивација Н/А

Material Selection & Биокомпатибилност

We offer a range of ISO 10993-certified materials:

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

medical-equipments

End-to-End Workflow

  1. Design review & ДФМ повратне информације
  2. Prototype fabrication (Сладолијармент, СЛС, ЦНЦ)
  3. Димензионална инспекција & functional testing
  4. Low-volume tooling or pilot production
  5. Batch manufacturing & ИСО 13485 documentation

Key Applications

Примена Примери
Surgical Instruments Ручке, 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:

  • ИСО 13485 Сертификовано управљање квалитетом
  • FDA design control guidance
  • Full traceability of materials and batches
  • Sterilization validation support
Medical_Device_Prototyping

Medical_Device_Prototyping

Зашто бирати Лангхе Цастинг?

  • 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

Често постављана питања

К1: Which sterilization methods do you support?

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

К2: Can you produce CE-marked prototypes?

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

К3: 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

Контактирајте нас

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

Е-маил: оутербоат@гмаил.цом
Телефон: +86 18838939163

Услуге

Сродне услуге