Σχέδιο, πρωτοτύπων και κατασκευή ιατρικών συσκευών

Πρωτοτυποποίηση και Κατασκευή Ιατρικών Συσκευών

(4967 Αναθεώρηση πελατών)

  • Προϊόντα ποιότητας παραγωγής
  • ISO 9001:2015 επικυρωμένος
  • 24/7 μηχανολογική υποστήριξη

Χύτευση 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: βιοσυμβατότης, 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 & Υπηρεσίες

Υπηρεσία Οφελος Τυπική ανοχή
Σλάδα & PolyJet 3D Printing High detail, ομαλές επιφάνειες ± 0,1 mm
SLS Nylon Prototyping Διαρκής, λειτουργικά μέρη ± 0,2 mm
Μηχανική κατεργασία CNC (Μέταλλο & Πλαστικά είδη) Production-grade accuracy ± 0,05 mm
Urethane Casting & Soft Tooling Low-volume, rapid turnaround ± 0,2 mm
Φινίρισμα επιφάνειας & Sterilization Prep Medical-grade polish, παθητικότητα N/A

Material Selection & Βιοσυμβατότητα

We offer a range of ISO 10993-certified materials:

  • Medical-grade ABS & PC-ISO
  • ΚΡΥΦΟΚΟΙΤΑΓΜΑ & 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 & Ανατροφοδότηση DFM
  2. Prototype fabrication (Σλάδα, SLS, CNC)
  3. Διαστάσεις επιθεώρηση & functional testing
  4. Low-volume tooling or pilot production
  5. Batch manufacturing & ISO 13485 documentation

Key Applications

Εφαρμογή Παραδείγματα
Surgical Instruments Λαβές, 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 πιστοποιημένη διαχείριση ποιότητας
  • FDA design control guidance
  • Full traceability of materials and batches
  • Sterilization validation support
Medical_Device_Prototyping

Medical_Device_Prototyping

Γιατί να επιλέξετε τη χύτευση 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

Συχνές ερωτήσεις

Ε1: Which sterilization methods do you support?

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

Ε2: Can you produce CE-marked prototypes?

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

Ε33: 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

Επικοινωνήστε μαζί μας

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

E-mail: [email protected]
Τηλέφωνο: +86 18838939163

Υπηρεσίες

Σχετικές υπηρεσίες