Medical Technology Regulatory Affairs - Sligo
Developed jointly by the University of Galway and ATU Sligo and in conjunction with an industry taskforce comprised of regulatory experts from the Irish Medtech Association (IMA) Regulatory and Quality Working Group, the course is supported by the Irish Medical Devices Association Irish Medtech Association (IMA) Skillnet.
Given the evolving nature of international regulations, a regulatory affairs professional must continually grow their knowledge and skills to be effective and to advance in their careers.
Introduction to EU Medical Technology Regulatory Affairs
Introduction to US Medical Technology Regulatory Affairs
Technical Report Writing
EU Medical Technology Regulatory Affairs- Advanced
US Medical Technology Regulatory Affairs Advanced
Risk Management, Labelling and Promotion
Global Medical Technology Regulatory Affairs Part 1
Clinical Evaluation Reporting
Quality Management System
Global Medical Technology Regulatory Affairs Part 2
Design Assurance, Sterilisation and Biocompatability
Post Market Surveillance
Medical Technology Regulatory Affairs Dissertation
Applicants require a Level 8 primary degree in a science/ engineering subject related to the life sciences.
Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions. The Research Project thesis will also be assessed.
2.5 years part-time, online.
One optional workshop, per semester.
EU students: MSc €12,000. Individual modules €900. Dissertation €2,500.
Non EU fees: €18,000 for MSc
Anyone living / working outside of Ireland and the EU for over 3 years pays non-EU Fees