MSc/ P.Grad.Dip in Regulatory Affairs for Medical Devices
Dublin, Ireland
DURATION
2 Years
LANGUAGES
English
PACE
Part time
APPLICATION DEADLINE
31 Jul 2024
EARLIEST START DATE
Sep 2024
TUITION FEES
EUR 13,160 / per year *
STUDY FORMAT
On-Campus
* Non-EU students| EU students: €6,270
Introduction
In recent years, the medical device regulation in Europe has undergone a fundamental redesign and this is leading to changes in market dynamics and the nature of the medical device ecosystem. Understanding these rules, and their application, is of increasing relevance to ensuring that MedTech organisations meet their strategic goals and will be a key advantage in career development in the sector.
This program will teach students about regulatory rules and principles, in addition to explaining the context in which these rules were developed, and how they have been implemented in Europe. The course will be delivered on a part-time basis over two years and has been designed to provide flexibility for students, who may already be working, to manage the challenge of balancing work, study, and family responsibilities.
Developed by regulatory specialists, in collaboration with leading clinical, academic, and industry experts, the programdaily will be delivered by professionals who contributed to the negotiations and implementation of Medical Device Regulation (MDR) in Europe, in addition to experts who apply MDR in practice on a daily basis.
Ideal Students
This course is offered to graduates looking to develop a career in a MedTech organization who would like to learn about European regulation of medical devices, and who may have an interest in becoming a person responsible for regulatory compliance.
Admissions
Scholarships and Funding
Academic scholarships for postgraduate international students are available at Trinity. Trinity rewards academic achievement and has sought to assist international students of limited means. Several scholarships are made possible by bequests and gifts that have been generously donated to the Trinity over the years.
- Global Excellence Postgraduate Scholarship
- AQ Scholarships
- Brazil Fundação Estudar Scholarship Program
- Haddad Foundation Brazilian Postgraduate Scholarship
- Brazilian Scholarship for Irish Studies - ABEI/HADDAD Fellowship
- China Scholarship Council
- Claddagh Scholarship Programme
- Comparative Social Change MSc Scholarships 2024/25
- E3 Balanced Solutions for a Better World Postgraduate Scholarship
- Energy Science MSc Scholarship
- Fulbright Scholars Programme
- Government of Ireland International Education Scholarships Programme
- Hong Kong Scholarship for Excellence Scheme
- Irish Research Council Scholarships
- Irish School of Ecumenics Scholarships
- Jean Monnet Scholarship Programme
- Jean Monnet School of Law Scholarships
- John Dillon Fellowship in Ancient Philosophy
- Loyola Institute Scholarships
- Mitchell Scholarship
- LPDP Scholarships for Indonesian Students
- Postgraduate Scholarship for Nigerian Students (Roger Casement Fellowship in Human Rights)
- Rachel Thompson Ussher Fellowship
- Reimagining Global Sustainability Postgraduate Scholarships
- Scholarships for Japanese Students
- Scholarships for MPhil in Race, Ethnicity and Conflict
- School of Law Scholarships
- School of Law and Trinity Business School - MSc Law and Finance
- School of Social Work and Social Policy International Postgraduate Taught Scholarship
- The Grattan Scholars
- The Hamilton Scholars
- Trinity – Intake Taiwan Joint Scholarship
- Victory Scholars Programme
Please contact us for more information regarding eligibility requirements, deadlines, and making an application.
Curriculum
To achieve the Masters's program, students must complete a dissertation, as well as the taught modules (worth 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 include:
- Introduction To Device Regulation, Regulatory Roles and Responsibilities
- Person Responsible for Regulatory Compliance
- Clinical Development Strategy
- Clinical Investigations
- Clinical Evaluation, Post-Market Assessment
- Biocompatibility and Medical Devices
- Risk Management and Medical Devices
- Quality Management and Conformity Assessment Pathways
- Qualification, Classification, Borderline Products and Device Traceability
- Preparing A Clinical Development Plan for a Novel Active Implanted Medical Device
- Regulatory Policy
- Research Project And Dissertation
Course Content
The course is a part-time taught program run over two years, with a total of 12 modules and a dissertation. Five modules are delivered online. In-person modules typically include three days of face-to-face teaching (combining formal teaching, workshops, and practical sessions).
Throughout the year participants are required to attend, in person or virtually, tutorials, workshops, lectures, networking events, and examinations. These are designed to facilitate students' working while undertaking the course. Tutorials accompany a majority of the online or in-person lectures.
Program Tuition Fee
Career Opportunities
Ireland is a global leader in medical device development, manufacturing and export, and it has the highest per capita employment in the MedTech sector in the EU. Medical devices are an increasingly important component of modern, integrated healthcare.
This programme will help graduates develop a career in a MedTech organisation, as well as enter the public- and private-sector regulatory environment for these devices. Graduates can also undertake further academic research at Trinity and other global universities.