COURSE TITLES
DURATION
Introduction to Healthcare Products Regulations
4 hours
Principles of safety, quality, effectiveness and risk
4 hours
Global Harmonization Frameworks
4 hours
Medical Device Regulatory Framework in the European Union
2 days
Medical Device Regulatory Framework in the United States
2 days
Medical Device Regulatory Framework in Australia
2 days
Medical Device Regulatory Framework in Canada
1 day
ISO 14971 Medical Device Risk Management
2 days
ISO 13485 Medical Device Quality Management System
2 days
US FDA Medical Device Quality System Regulation
2 days
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