Master of Science in Medical Device Regulatory Affairs

  • Master of Science Medical Device Regulatory Affairs
  • NFQ Level 9
  • Details available on the Admissions-Postgraduate pages
  • 2 Years Part-time / 1 Year Part-time
  • Carlow
  • Postgraduate Diploma in Science in Medical Device Regulatory Affairs (Level 9 - 60 credits)
  • Overview
  • Entry Requirements
  • Further Study & Careers
  • PAC Codes & Fees
  • How to apply
  • Contact


This Master of Science in Medical Device Regulatory Affairs presents students with the opportunity to skills to employers and peers, and to enhance your career in regulatory affairs by developing increasing levels of competence and professionalism. It is the ‘gold standard’ in the field.

Students will gain invaluable access obtain a formal qualification in the medical device regulation industry. The programme presents a broad view of the regulatory affairs role  and provides a detailed insight into current and proposed EU legislation. It provides students with an advanced theoretical understanding of the processes and practices central to medical device regulatory affairs.

The medical device sector is highly diverse. It covers thousands of products – from simple bandages and spectacles, through implantable devices, equipment for screening, to the most sophisticated diagnostic imaging and minimally invasive surgical equipment. Strong growth prospects for the industry globally are driven by ageing populations, increase in chronic ailments and increasing consumer wealth driving demand in emerging economies.

A formal qualification is the ideal way to demonstrate your existing to industry professionals and networking events to help develop their careers. There are limited places available on this programme – class sizes are kept relatively small to help create an interactive environment and to ensure each student receives excellent support from our academic team.

What will I be able to do when I finish this programme?

This MSc will allow students to develop a set of transferable  skills that will directly meet the requirements of future  employers including information technology, written and verbal communication skills, team working, independent research skills, data analysis and critical thinking.

What subjects will I study?

  • Regulatory Affairs Quality Management and Strategy
  • Research Methods and Technical Report Writing
  • Medical Device Technologies: Design, Development and Testing
  • Medical Technology Regulatory Affairs
  • Product Programme Management, Vigilance, Surveillance and Risk Management
  • Clinical Evaluation of Medical Device Technologies

NOTE: Specific modules may be subject to amendment after our 2021 programmatic review.

Entry Requirements

Applicants require a second class honours degree or higher, or an equivalent in a science, business or management subject. Other applicants will be considered on an individual basis in accordance with the Institute policy on Recognition of Prior Learning (RPL). IT Carlow reserves the right to require applicants to attend for an interview to determine their suitability for the programme.

Study Opportunities

Opportunities for graduates from this programme include progression to Level 10 (PhD) programmes in related fields of study.

Potential employment opportunities

This MSc provides graduates with an advanced theoretical understanding of the processes and practices central to medical device regulatory affairs. Graduates can move into regulation roles and/or be promoted within their organisation.

Ireland is one of the leading global medical devices industry centres. There is a very strong multinational presence in the sector with many of the top medical devices and related global companies basing in Ireland.

The medical devices sector also links in strongly with the ICT and engineering base, for example as key partners in delivering healthcare solutions (Nypro, HP, IBM, Analog and Intel). In its 2013 report, the Expert Group on Future Skills Needs (EGFSN, 2013)  reported  on requirements of the Manufacturing sector to 2020, in which they predict employment to continue to increase by 43,000 by 2020.

The report included the Medical Devices sector as one of the subsectors driving this demand. The Irish Medical Devices Association (IMDA) represents over 170 organisations in Ireland and works with government and policy makers nationally and internationally to drive economic growth in the sector. According to the IMDA, there is now a shift in consumer technology companies making inroads into medicine and Ireland is uniquely placed to harness and leverage the opportunity between these industries. According to a medical devices regulatory affairs manager consulted as part of the development of the proposed programme, ‘all major medical device multinational companies now have sites in Ireland and there is a major need for graduates to support the sector who have an expertise in regulatory affairs’.

Programme Codes & Fees

Programme Code Programme Title Campus Location Schedule Fees Closing date for applications
CWL13 Master of Science in Medical Device Regulatory Affairs Carlow Part-time €7,400* Full details available on the Admissions pages
CWL14 Postgraduate Diploma Medical Device Regulatory Affairs Carlow Part-time €5,500 Full details available on the Admissions pages
CWL34 Master of Science in Medical Device Regulatory Affairs Carlow Full-time €7,400* **
Full details available on the Admissions pages
  * Fees for ITC Major Award graduates only €5,500

** SUSI funding not available

How to apply

  1. Research & choose your programme from our wide range of postgraduate offerings on our website or in our prospectus.
  2. Check all of the relevant programme information including entry requirements, programme code and closing dates, taking time to read the Application Instructions.
  3. Get started on your postgraduate journey at IT Carlow!

For admissions queries, please email:


Eoin O'Brien
BA, DBS, CBS, Cert Mgmt, MBA
Lifelong Learning Manager
P: 059 917 5280