Course Content
Year 1 (30 Credits)
- Required MTR5101: EU Medical Device Regulatory Affairs - Introduction
- Required MTR5102: US Medical Device Regulatory Affairs - Introduction
- Required MTR5103: Technical Report Writing
- Required MTR5104: Global Medical Technology Regulatory Affairs Part 1
- Required MTR5105: Clinical Evaluation
- Required MTR5106: Quality Management Systems
Year 2 (60 Credits)
- Required MTR5107: EU Medical Technology Regulatory Affairs Advanced
- Required MTR5108: US Medical Device Regulatory Affairs - Advanced
- Required MTR5109: Risk Management, Labelling and Promotion
- Required MTR5113: Medical Technology Regulatory Affairs DISSERTATION
- Required MTR5110: Global Medical Technology Regulatory Affairs Part 2
- Required MTR5111: Design Assurance, Sterilisation and Biocompatability
- Required MTR5112: Post Market Surveillance
