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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.
  The quallity managment system should be comliant with New Regulation set forth in April 2017
1. MDR 745/
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices
2. IVDR 746/Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevant)
3. 
ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.
4. 
PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

What is the content of PD CEN/TR 17223:2018?
This standard PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation is classified in these ICS categories:
  • 03.100.70 Management systems
  • 11.040.01 Medical equipment in general
This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.
  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