Services & Capabilities


Contract Development & Manufacturing Solutions



Contract Development & Manufacturing Solutions


• End-to-end solutions from design to market

• Support for both medical and non-medical applications


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Material Formulation
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Material Formulation


• Design verification and feasibility studies

• Custom product development and innovation



Manufacturing Capability



Manufacturing Capability


• Cleanroom manufacturing (Class 100,000 / ISO 8)

• Multi-material extrusion and molding

• Auto-assembly production lines


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Quality Capability
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Quality Capability 


▸ Verification & Validation Capability

  • Product testing and functional evaluation

  • Biocompatibility and shelf-life testing

  • Design validation protocols

▸ Registration Capability

  • Support with CE, FDA, NMPA, and global filings

  • Dossier preparation and submission

  • Technical documentation and labeling

▸ QMS Capability

  • ISO 13485-certified quality systems

  • CAPA, audit readiness, risk management

  • Traceability, batch control, and documentation

▸ Small Trial Capability

  • Rapid prototyping

  • Limited batch production for testing or market trials

  • Steam Sterilization (Autoclave)


Sterilization Capability



Sterilization Capability

• Gamma Sterilization

• EO (Ethylene Oxide) Sterilization

• EBM (Electron Beam) Sterilization


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Tooling Capability1
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Tooling Capability


• In-house mold/tool design and fabrication

• Tool validation and maintenance

• Rapid tooling for short-run products






Global Supply Chain & 

Logistics Capability


• Worldwide delivery and shipping support

• Cold chain and sterile packaging logistics

• Vendor-managed inventory and warehousing


Global Supply Chain & Logistics Capability
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Tooling Capability
Auto Assembly Capability





Auto Assembly Capability


• Semi-automatic and fully automatic assembly lines

• Assembly under controlled conditions (cleanroom, dry room)

• Custom automation for complex product builds





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新建锚点7
Project Management Capability
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Project Management Capability


• Cross-functional coordination from concept to commercialization

• Timeline tracking, resource management, and risk mitigation

• Client-focused communication and reporting systems





 

Hantech Medical Italy S.p.A.

Address: Via G. Matteotti, 27/A - 45030 Villamarzana (RO) Italy

Phone: +39 347 5798989  

WhatsApp: +39 347 5798989      

E-mail: infoitaly@hantechmedical.com

 


             

Copyright © 2025-2027 Hantech Medical Italy S.p.A. All Rights Reserved. 

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