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Quality Management

Home | Our Service | Quality Management

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

Our Service

Jens Medical Consulting Ltd.

TEL：886-2-82823192｜FAX：886-2-82867686｜E-Mail：jen.medical@msa.hinet.net
3F. No 364, Jixian RD, Luzhou Dist. New Taipei City, Taiwan ROC

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