
Retention of RA/QA experts
Rapid response to changes in regulations
Continuous follow-up management

A variety of linked certifications
Technical advisor efficiency and accuracy
One Stop Service

Global network for Overseas Certification Institutions
Europe, USA, Japan, China, etc.
Regional experts in each country

Auditor field in Instructor
Professional and differentiated training service

In vitro diagnostic reagent manufacturing, import business, IVD certification, GMP certification, 3rd Party Holder

Medical device manufacturing, import business, IVD certification, GMP certification, 3rd Party Holder

US FDA, EUROPE CE MDR / IVDR, JAPAN PMDA, CHINA NMPA, Global agent service

ISO International Auditor Training, GMP/ ISO 13485 Internal Auditor Training, In vitro diagnostic/ Medical Device RA Training
- Facility Registraytion & U.S Agent
- Product Registration
- Renew (product, facility, U.S Agent)
- ISO 13485 (In vitro diagnostic / Medical device)
- FDA (In vitro diagnostic / Medical device/Cosmetics)
- CE (In vitro diagnostic / Medical device)
Working Time : 09:00 ~18:00/ Linchtime 12:00~13:00
