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We are the first membrane switch manufacture to attain ISO13485 in Asia and uniquely positioned to effectively support this product class.
We provide
  • Substrate: polyester or polyimide foil with lamination softness.
  • Screening: AG/AGCL and Dielectrics.
  • Dispensing: hydro gel and conductive adhesive.
  • ISO13485 certification.
  • No Change Policy.
  • Class 10,000 clean room and Sterilization Control.
  • QSR (Quality System Regulation) level documentation & quality standard meet FDA requirement.
  • CAPA system implement (Corrective Action & Preventive Action).
  • APQP (Advanced Product Quality Planning):
        -  Flow Chart
        -  Control Plan
        -  PFMEA
  • V&V Protocol & Reports: (Verification & Validation)
        - IQ (Installation Qualification): Tooling Calibrations.
        - OQ (Operation Qualification): DOE Analysis.
        - PQ (Performance Qualification):
       3 Validations run to assure production process stability.
 

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