Medical Device Regulatory Affairs & Quality - Sligo

This programme, developed jointly by the University of Galway and ATU Sligo, has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles. The course will enable Regulatory Affairs and Quality 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 everchanging global environment of regulatory affairs and quality.

Modules

Introduction to Quality Management Systems

Fundamentals of EU Medical Device Regulations

Auditing and Compliance

Fundamentals of US Medical Device Regulations

Risk Management and Design Control

Validation and Calibration

Fundamentals of Global Medical Device Regulations

Sterilisation and Biocompatibility

Operations Management and GMP

Fundamentals of Medical Device Clinical Trials

Introduction to Market Vigilance and Labelling

Technical Report Writing

Level 7 qualification in a relevant area of Science, Engineering or Technology.



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.

2 years part-time. Delivery Method: Online.



On-Campus Attendance: One optional workshop each year which is an opportunity to meet lecturers and network with other students.

Start Date: September 2025.