Medical Device
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Medical Device Quality System

Our experienced consultant could assist in establishing Medical Device Quality

Management System including Documented Procedures Preparation, Quality

Assurance Plan, Internal Audit, and Quality Management Training to meet the

government authority requriement or the expectation of the unscheduled

customer inspection.
  • Taiwan QMS 
  • EU ISO 13485 for Medical Device Manufacturer in compliance with MDR/IVDR

  • US FDA Quality System Regulation (QSR) for Medical Device Manufacturer in
        compliance with Requirement in part 820 (21 CFR part 820)
  • MDSAP qaulity managment system in compliance with US FDA, Brazile GMP,

    Health Canada, Japan, Australia
in addtion, we also could assist in estachlishing GDP for medical device importer.