MGMT X442.6

Medical Device Quality Systems

A required course in the Certificate Programs Medical Device Development and Regulatory Affairs and Compliance.

Learn about the essential elements of Quality System Regulations (QSR's) and Good Manufacturing Practices (GMP's), how there is a commonality between them, and how to develop a global approach to Quality Systems in order to satisfy international requirements of ISO 13485:2016. A detailed analysis of these systems and practical 'how to' recommendations and approaches are presented, with particular emphasis on the United States Food and Drug Administration (FDA) QSR's and GMP's.

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Course
Approximate Cost $735
Format Online
Duration 10 Weeks
Total Credits 3

WINTER 2024

1/8/2024 - 3/17/2024
Weeks 10
Delivery Online
Fee $735
Status Closed

SUMMER 2024

6/24/2024 - 9/1/2024
Weeks 10
Delivery Online
Fee $735
Status Open