Medical Device 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 and 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

Global Medical Technology Regulatory Affairs Part 1

Clinical Evaluation Reporting

Quality Management System

Applicants require a Level 8 primary degree in a science/engineering subject related to the life sciences.



Recognition of Prior Learning: Yes

Flexible learning courses are popular, and they fill on a first come, first served basis. 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 webpage.

1 year 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.

Progression Pathways

Many of our Masters programmes are structured in a way that includes recognised entry and exit awards. This means that you can apply for part of Masters first and learn at your own pace or if you are unable to complete the full programme, you can still gain a recognised qualification. Our entry and exit awards typically include Postgraduate Certificate award and a Postgraduate Diploma award.