Medical Technology Regulatory Affairs & Quality - Sligo

This programme has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by NUI Galway and ATU Sligo in conjunction with selected external professionals and industry practitioners who have all the required expertise, knowledge, skills and experience to deliver the education and training required to the highest international standards.



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 ever-changing global environment of regulatory affairs and quality. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 60 credits.

Year 1



Semester Module Details Credits Mandatory / Elective

1 Introduction to Quality Management Systems 05 Mandatory

1 Fundamentals of EU Medical Device Regulations 05 Mandatory

1 Auditing and Compliance 05 Mandatory

2 Fundamentals of US Medical Device Regulations 05 Mandatory

2 Risk Management and Design Control 05 Mandatory

2 Validation and Calibration 05 Mandatory



Year 2



Semester Module Details Credits Mandatory / Elective

1 Fundamentals of Global Medical Device Regulations 05 Mandatory

1 Sterilisation and Biocompatability 05 Mandatory

1 Operations Management and GMP 05 Mandatory

2 Fundamentals of Medical Device Clinical Trials 05 Mandatory

2 Introduction to Market Vigilance and Labelling 05 Mandatory

2 Technical Report Writing 05 Mandatory

Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme. Applications from candidates who hold a Level 7 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and /or regulatory affairs will be considered. Candidate interviews may be used to assess candidates suitability for the programme. Students applying on the basis of formal qualifications and supplementary accredited prior learning (APL) for core pre-requisites will be required to submit full details and references to the Programme Board for consideration of educational equivalencies. Prior experiential learning will be assessed using guidelines recommended by the Academic Council of ATU Sligo and University of Galway.

Application Closing Date 14th August 2026

2 years part-time, online.



On-Campus Attendance Requirement

One optional workshop each year which is an opportunity to meet lecturers and network with other students



Note: Check programme Examination and Assessment requirements, as they may involve examinations to be taken on campus.

Start Date September 2026

Progression

Graduates with the Higher Diploma award will be eligible to apply to undertake the MSc. in Medical Technologies Regulatory Affairs, a part-time distance learning Level 9 programme jointly delivered by University of Galway and ATU Sligo.



Careers

This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs or Quality environment within the highly successful and growing Irish Medical Technology industry sector.



The Level 8 Higher Diploma and Certificate in Medical Technology Regulatory Affairs and Quality programme has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a taskforce comprised of regulatory experts from industry, industry practitioners and representatives from the regional skills for a west and north west.



The Irish Medical Devices Association (IMDA) states “The medical technology sector in Ireland is recognised as one of the five global emerging hubs. The sector employs over 29,000 people in Ireland and is the second largest employer of medtech professionals in Europe. Ireland is one of the largest exported of medical products in Europe with annual exports of €12.6 billion and companies here directly export to over 100 countries worldwide. As many as 18 of the world’s top 25 medical technology companies have a base in Ireland and 50% of the 450 medtech companies based here are indigenous.”



The sector is, by its nature, highly regulated; all disciplines involved in the design, manufacture and distribution of a medical device are controlled by medical device regulations. Given the unique need for regulatory affairs knowledge and understanding at all stages of a medical device product lifecycle there is a strong need for the medical technology industry to have available to it appropriate courses to satisfy this information and skills need. The Forfás National Skills Bulletin 2016 further supports this need as it identified a skills shortage for regulatory professionals and quality control engineers.