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Quality Management
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Quality System Assurance Consultancy
Our experienced consultant could assist in establishing Quality System Management System including Quality System Documents Preparation, Quality Assurance Plan, Internal Audit, and Quality Management Training to meet the government authority or unscheduled customer inspection.
 
   
  Medical Device Importer entering Taiwan Market
  It is necessary to get Taiwan QSD number before granting product approval in order to prove that the physical manufacturer out of Taiwan is compliant with Taiwan GMP. You may provide quality system documents for review instead of overseas inspection.
   
  Medical Device Manufacturer
 
  • Taiwan GMP for Domestic Physical Manufacturer
  • EU ISO 13485 for Medical Device Manufacturer in compliance with MDD/IVDD/AIMDD
  • US FDA Quality System Regulation (QSR) /MDSAP/GMP for Medical Device Manufacturer in compliance with Requirement in part 820 (21 CFR part 820)
  • GDP for medical device importer
   
  Testing Lab Accreditation
  In compliance with ISO 17025 for CNLA, ILLAC…accreditation
   
  Clinical Lab (Medical Lab) Accreditation
  In compliance with ISO15189 standard for COLA and CAP accreditation