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.