Regulatory Affairs for Medical Devices (M.Sc./P.Grad.Dip)
The course is a part-time taught program, run over 2 years for a total of 12 modules, with a dissertation to be completed by August of year 2. 5 modules are delivered online. Each inperson module typically has 3 days face-to-face teaching which consists of a combination of formal teaching sessions, workshops, and interactive/practical sessions. Pre-module reading lists and self-directed learning material are provided and form part of the module teaching. In addition, all registered students have access to Trinity’s web-based virtual learning environment facility. Students are expected to interact with other class members and the course coordinators via the e-learning platform. Throughout the year participants are required to attend, either in person or virtually, a number of module tutorials, workshops, regulatory lectures, networking events and examinations. These have been designed to facilitate students who are working in addition to undertaking the course. Each module contains several sessions. Tutorials accompany a majority of the online or inperson lectures. Details regarding the schedule for tutorials will be released at the beginning of each module and an indicative timetable is included in the student handbook. Course Content and Structure (Modules) To achieve the MSc, students must complete a dissertation, in addition to completing taught modules, totalling 90 ECTS. The distribution of credits is 45 ECTS of taught modules in year 1 and 45 ECTS in year 2, including 30 ECTS of research dissertation. These modules are: 1) M1. Introduction to device regulation, regulatory roles and responsibilities 2) M2. Person responsible for regulatory compliance 3) M3. Clinical development strategy 101 4) M4. Clinical Investigations 5) M5. Clinical evaluation, post-market assessment 6) M6. Biocompatibility and medical devices 7) M7. Risk management and medical devices 8) M8. Quality management and conformity assessment pathways 9) M9. Qualification, classification, borderline products and device traceability 10) M10. Preparing a clinical development plan for a novel active implanted medical device. 11) M11. Regulatory policy 12) M12. Research project and dissertation
Course Details
Number of Places
Minimum EU 5 Maximum EU 20 Minimum non-EU 0 Maximum non-EU 5 Places
Next Intake
September 2023
Course Coordinator
Associate Prof. Tom Melvin
Course Director
Associate Prof. Tom Melvin
Closing Date
31st July 2023
Admission Requirements
Applicants are expected to have an Honours Bachelor degree ideally 2.1 or above in one of the following disciplines: pharmacy, medicine, allied health professions, biomedical engineering, biology, law. Other disciplines may also be considered as suitable on a case-by-case basis, and an interview may be offered to assess suitability. Applicants will ideally have some experience in MedTech development, manufacturing or regulation, however applicants with other relevant experience are welcome to apply
Apply
To apply, click on the relevant Apply Link below
