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ACCEPT AND PROCEED
[NEW] Non-PVC /PVC-free Electrosurgical Products [NEW] Angled Electrodes [NEW] 510K declared-Shinmed Smoke Evacuation Pencil─ShinEvac® Classic, AIO [NEW] "Disposable ESU Pencil with Insulated Electrode [NEW] "Contract Manufacting
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Contract Manufacting

Contract Manufacturing

Contract Manufacturing:

  • Device assembly
  • Injection/Molding
  • Sterilization
  • Material consulting

Medical Device Cable:

  • Customized cable
  • In-house HF Voltage test

ODM:

  • Fast Prototyping
  • 3D drawing
  • DFM, V&V for medical device
  • Product Improvement/Study

Primary Competitive Advantages

  • Quality control
  • Packaging Inspection
  • Cleanroom control
  • Immediate service

QC

IQC:

  • Raw material from Taiwan supplier/ manufacturer
  • IQC inspection
  • Qualified supplier

IPQC:

  • Injection, Moulding, Soldering, Assembly…
  • IPQC for each process
  • ISO 8 cleanroom
  • USP1116 Microbiological control
  • ISO14644-14 Air Quality
  • Cleanliness & Sterilization
  • ISO 11135 Sterilization Validation
  • ISO 11737 Bio-burden

FQC/OQC:

  • Final conduction test
  • 100% HIPOT test
  • EN 868 Packaging test
  • US FDA approved sterilization plant
  • BI/CI indicator and test

Standards & Approvals

ISO13485, ISO2859-1

R & D

1. Discussion:

  • Product Spec
  • Packaging
  • Smoke Evac. Plan
  • Lap. Instrument Plan
  • Private Label

2. Confirm Inquiry:

  • Proposal
  • Trial

3. Cooperation:

  • Sales contract
  • NDA

4. Registration:

  • Application process

5. Distribution:

  • Shipment schedule

Location: TAIWAN

Contact Detail
Contact:International Sales Team
Address:No. 22, Lane 116, Wugong 2nd. Rd., Wugu Dist., New Taipei City, 24888, Taiwan, R.O.C.
TEL:+886-2-22900966
FAX:+886-2-22903966
Email:export@shinmed.com
URL:http://www.shinmed.com