Medical Technology Regulatory Affairs - Sligo

This course will enable Regulatory Affairs personnel in the Medical Technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of regulatory affairs. 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.



Recognition of Prior Learning: Yes.

When to Apply

There are two major intake periods throughout the academic year, September and January. For January start courses, applications typically open in October, and for September start courses, applications typically open in February. Closing dates for applications are listed on the individual course webpages.

2.5 years part-time, online delivery.



Study Hours

The programme consists of 12 modules, each worth 5 credits. Three modules are delivered per semester. A dissertation (30 credits) is also carried out over Year 1 and Year 2.



On-Campus Attendance: One optional workshop, per semester.

Start Date: September 2026.