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.

Modules



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.

90

2.5 years part-time, online.



On-Campus Attendance

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


http://www.nuigalway.ie/student-fees/international/​