Course Content
Year 1
Semester 1 Modules (each module is 5 ECTS)
- Introduction to Quality Management Systems
- Fundamentals of EU Medical Device Regulations
- Auditing and Compliance
Semester 2 Modules (each module is 5 ECTS)
- Fundamentals of US Medical Device Regulations
- Risk Assessment
- Validation and Calibration
Year 2
Semester 3 Modules (each module is 5 ECTS)
- Fundamentals of Global Medical Device Regulations
- Sterilisation & Biocompatability
- Operations Management. and GMP
Semester 4 Modules (each module is 5 ECTS)
- Fundamentals of Medical Device Clinical Trials
- Introduction to Market Vigilance & Labelling
- Technical Report Writing
