Ukuklama, prototyping kanye nokukhiqiza imishini yezokwelapha

I-Medical Device Prototyping kanye Nokukhiqiza

(4967 Ukubuyekezwa Kwamakhasimende)

  • Imikhiqizo yezinga lokukhiqiza
  • Isethulo 9001:2015 eqinisekisiwe
  • 24/7 ukwesekwa kwezobunjiniyela

I-LANGHE 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: biocomthation, 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 & Amasethingi

Ukusebenzela Zuza Ukubekezelela Okujwayelekile
Isiporoti & PolyJet 3D Printing High detail, Izindawo ezibushelelezi ± 0.1 mm
SLS Nylon Prototyping -Qinile, izingxenye ezisebenzayo ± 0.2 mm
Imishini ye-CNC (Izinsimbi & Ipulasitiki) Production-grade accuracy ± 0.05 mm
Urethane Casting & Soft Tooling Low-volume, rapid turnaround ± 0.2 mm
Ukuqedwa komhlaba & Sterilization Prep Medical-grade polish, ukwedlulisa N/A

Material Selection & I-Biocompatibility

We offer a range of ISO 10993-certified materials:

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

medical-equipments

End-to-End Workflow

  1. Design review & Impendulo ye-DFM
  2. Prototype fabrication (Isiporoti, Isi-SLS, CNO)
  3. Ukuhlolwa kobukhulu & functional testing
  4. Low-volume tooling or pilot production
  5. Batch manufacturing & Isethulo 13485 documentation

Key Applications

Isicelo Izibonelo
Surgical Instruments Nibangela, 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:

  • Isethulo 13485 ukuphathwa kwekhwalithi eqinisekisiwe
  • FDA design control guidance
  • Full traceability of materials and batches
  • Sterilization validation support
Medical_Device_Prototyping

Medical_Device_Prototyping

Kungani ukhethe ukulahla i-langhe?

  • 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

imibuzo ejwayelekile ukubuzwa

Q1: Which sterilization methods do you support?

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

Okwabomvana: Can you produce CE-marked prototypes?

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

I-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

Xhumana nathi

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

Ivangeli: [email protected]
Ifoni: +86 18838939163

Amasethingi

Izinsizakalo Ezihlobene