Courses on Medical Device Regulations

The following is a catalogue of medical device courses offered by Semoegy and taught by Dr. Nealda Yusof. This is not a comprehensive list. If you require medical device courses not listed here, please contact us with your request.

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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