About
Medical Device Service in PIDC
One-stop Medical Device Development Service
Focus on the field of polymer materials
Plastic Industry Development Center cooperates with the industry, we are a strategic partner for medical product development and research.
Safety Evaluation of Medical Devices
Focus on the field of polymer materials
Test verification validation of medical devices, we provide
■ In compliance with Principles of ISO/IEC 17025 & OECD GLP & TFDA GLP
■ Fully integrated, comprehensive laboratory services
■ Planning for safety evaluation of product
Biomedical Department
R & D • Test & Verification • System Verification
Biomedical Technology
  • Medical device study, design & processing
  • Design and Analysis (PP、PVC、TPU、Silicone….)
  • Surface modification technology
Medical Device Test & Verification
  • Pre-Clinical Product Testing Requirement
  • Biocompatibility Test
  • Package Integrity & Sterilization Validation Test/Full Report
  • Pharmaceutical Chemical Migration Test
  • Microbe Test
  • Product Functional & Product Durability Test
Medical Device-ISO 13485 and QMS quality system construction consulting
  • ISO 13485 quality system construction consulting
  • QMS Certification service
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    Taiwan TFDA Medical Device Registration
    TFDA Medical Devices Consultant to register QSD and products permit licenses. Prepare required documents and after-application follow-ups.
    We can provide you the professional and value-added assistance whether an existing medical device category or an innovative, high-risk medical device. From determining the application pathway to researching and documentary preparing our team can help, making you fully understand the regulations of medical devices, so that your product can be certified lightning-fast and then put on the market.
    Diagnosis of the Technical Documents
    • Risk Management Report (ISO 14971)
    • Human Factors Engineering Report (IEC 62366-1)
    • Clinical Evaluation Report
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    PIDC's Medical Device Service connects clinical and application research and development, and builds a medical, industry, academic, and research exchange platform.

    Plastics Industry Development Center
    Biomedical Department
    No.59, 39th Rd., Taichung Industrial Park, Taichung City 40768, Taiwan, R.O.C.
    +886-4-23595900
    pidc@pidc.org.tw
    Copyright © PIDC All Rights Reserved.
    pidc@pidc.org.tw