Quality Management System Establishment & Amendment

U.S.A.

Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP)

EU

MDR

IVDR

Taiwan

Quality Management System (QMS)

Quality System Documentation (QSD)

Good Distribution Practice (GDP)

MDSAP

Japan

Australia

U.S.A.

Canada

Brazil

ISO 13485

ISO 13485 Certification

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