Iddisinjar, prototipi u manifattura ta' apparat mediku

Prototipi u Manifattura ta' Apparat Mediku

(4967 Reviżjoni tal-Klijent)

  • Prodotti ta 'grad ta' produzzjoni
  • ISO 9001:2015 Ċertifikat
  • 24/7 appoġġ għall-inġinerija

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: Bijokompatibilità, 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 & Servizzi

Servizz Benefiċċju Tolleranza tipika
SLA & PolyJet 3D Printing High detail, Uċuħ lixxi ± 0.1 mm
SLS Nylon Prototyping Durabbli, Partijiet funzjonali ± 0.2 mm
Magni CNC (Metalli & Plastik) Production-grade accuracy ± 0.05 mm
Urethane Casting & Soft Tooling Low-volume, rapid turnaround ± 0.2 mm
Irfinar tal-wiċċ & Sterilization Prep Medical-grade polish, passivazzjoni N/A

Material Selection & Bijokompatibilità

We offer a range of ISO 10993-certified materials:

  • Medical-grade ABS & PC-ISO
  • Peek & 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 & Feedback DFM
  2. Prototype fabrication (SLA, SLS, CNC)
  3. Spezzjoni dimensjonali & functional testing
  4. Low-volume tooling or pilot production
  5. Batch manufacturing & ISO 13485 documentation

Key Applications

Applikazzjoni Eżempji
Surgical Instruments Mankijiet, 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 Ġestjoni tal-kwalità ċċertifikata
  • FDA design control guidance
  • Full traceability of materials and batches
  • Sterilization validation support
Medical_Device_Prototyping

Medical_Device_Prototyping

Għaliex Agħżel 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

Mistoqsijiet frekwenti

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?

IVA, 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

Ikkuntattjana

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

Email: [email protected]
Telefon: +86 18838939163

Servizzi

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