| Course Name |
Medical Device Regulatory Affairs |
| Course Provider |
SETU - Carlow Campus |
| Alternative Provider(s) |
SETU - South East Technological University |
| Course Code |
CWL34 CWL13 CWL14 |
| Course Type |
Postgraduate |
| Qualifications |
| Award Name | NFQ Classification | Awarding Body | NFQ Level |
| Degree - Masters (Level 9 NFQ)
More info...
|
Major |
South East Technological University |
Level 9 NFQ |
| Postgraduate Diploma (Level 9 NFQ)
More info...
|
Major |
South East Technological University |
Level 9 NFQ |
|
| Apply To |
PAC |
| Attendance Options |
Full time, Part time, Daytime |
| Location (Districts) |
Carlow Town |
| Qualification Letters |
MSc |
| PAC Application Information |
Expand+Course Codes:
CWL34 Master of Science in Medical Device Regulatory Affairs CARLOW Full-time
CWL13 Master of Science in Medical Device Regulatory Affairs CARLOW Part-time
CWL14 Postgraduate Diploma Medical Device Regulatory Affairs CARLOW Part-...
Hide-Course Codes:
CWL34 Master of Science in Medical Device Regulatory Affairs CARLOW Full-time
CWL13 Master of Science in Medical Device Regulatory Affairs CARLOW Part-time
CWL14 Postgraduate Diploma Medical Device Regulatory Affairs CARLOW Part-time
Entry 2022/2023
Please note that all postgraduate applications for taught programmes at Institute of Technology Carlow should be completed online via PAC (Postgraduate Application System) www.pac.ie
It is important to note that each programme has a different PAC code based on award level, schedule and campus location.
Timetabled hours may include daytime, evening and Saturday classes.
HOW TO APPLY
APPLICATION PROCESS - TAUGHT PROGRAMMES
Please note that all Non-EU international student applicants must apply through our International Office. Please refer to the International section of the prospectus or our website: www.itcarlow.ie/international/non-eu-students or alternatively email: internationaladmin@itcarlow.ie.
Application process steps
1. Choose your programme(s) from our prospectus or online postgraduate programme listing on the Institute website.
It is very important that you review all of the following before applying:
• Entry requirements
• Supporting documentation requirements for your application
• Course modules and information
• Schedule and location (i.e. part-time or full time, and which campus you would like to attend)
• Fees
• Relevant PAC code
• Closing dates for applications.
Should you have any queries, or need further information on a particular programme of study, please contact the relevant programme director or head of department listed on the individual programme.
2. Register with PAC online at www.pac.ie and gather all supporting documentation required for your application (e.g. references, CV, personal statement etc.).
Scanned copies of your supporting documentation must be uploaded to www.pac.ie. Alternatively, supporting documentation can be posted to the Postgraduate Applications Centre, 1 Courthouse Square, Galway. Please note that supplementary documentation should be sent within 7 days of your online application. Documents must be in a clear format, of good quality and a readable size.
Poor quality/unreadable documents may affect the assessment of your application.
3. Apply online at www.pac.ie.
The PAC online application system is now open for new postgraduate applications for the academic year 2022/2023. This is an online application system that allows applicants, for a non-refundable fee of €50 paid directly to PAC, to apply for multiple postgraduate programmes at Institute of Technology Carlow. Applications will be considered in order of preference. If you are successful in receiving an offer on your first preference or first choice of programme, all other preferences will be excluded. Similarly, if you are unsuccessful in your first preference, then your second preference will be considered and so on.
Course selection may be from any of our Masters, Higher Diploma and Postgraduate Diplomas.
PAC may be contacted for support via email: pachelp@pac.ie or through the website. Applicants may contact Admissions via email: graduatestudies@itcarlow.ie.
To ensure a place on your chosen course we advise registering as soon as possible. Certain programmes are restricted to a limited number of applicants and places on these courses are assigned on a first-come-first-served basis. Late applications will be considered on a case-bycase basis.
Institute of Technology Carlow reserves the right to request that some applicants attend for interview to determine their suitability for individual programmes.
4. Review application status via the My Account section on the PAC website.
All applicants will be notified by email of changes to the status of their application. Alternatively, applicants may login online any time to the PAC system under the My Account section to view their application. Applicants who receive an offer have 14 days to accept or decline that offer. Applicants who accept must also pay a deposit of €500 within 14 days which may be paid online via the PAC system. This deposit is then offset against the full tuition fee.
5. Getting started
Applicants who accept their offer should keep up-to-date by logging onto the Institute website. Our academic year starts in September and academic timetables and other news and events will be posted on the website and on other social media such as Facebook, LinkedIn, Twitter and Instagram.
|
| Application Weblink |
Web Page - Click Here |
| Duration |
1 year full-time, 2 years part-time. |
| Course Fee |
CWL34 Master of Science in Medical Device Regulatory Affairs CARLOW Full-time €7,400*
CWL13 Master of Science in Medical Device Regulatory Affairs CARLOW Part-time €7,400*
CWL14 Postgraduate Diploma Medical Device Regulatory Affairs CARLOW Part-time €5,500
*Fees for ITC Major Award graduates only – €5,500.
Programme Fees for Non-EU Students:
Masters Programme Fee - €11,250. |
| Link to Course Fee |
Web Page - Click Here |
| 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. |
| Comment |
NOTE: All programmes are offered subject to sufficient numbers of students. This document is intended as a guide to programmes. While every effort has been made to ensure the completeness and accuracy of the information contained in this publication at the time of print, Institute of Technology Carlow reserves the right to make changes to any content, schedules or fees. |
| Course Content |
What is the programme about?
This 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. |
| Subjects Taught |
What subject areas 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
Research Dissertation |
| Number of Credits |
Master of Science in Medical Device Regulatory Affairs 90 Credits
Postgraduate Diploma Medical Device Regulatory Affairs 60 Credits |
| Careers or Further Progression |
Expand+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 communica...
Hide-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 follow-on study opportunities are available?
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. The medical technology (medtech) sector employs over 29,000 people in Ireland and is the second largest employer of medtech professionals in Europe.
There is a very strong multinational presence in the sector with many of the top medical devices and related global companies based in Ireland. Exports of medical devices and diagnostic products now represent 8% of Ireland’s total merchandise exports. 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). 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’.
Exit award
Students who successfully complete the relevant 60 credits of the programme will be eligible for the Postgraduate Diploma in Medical Device Regulatory Affairs (Level 9) should they opt to leave the programme (Embedded Exit Award).
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| Further Enquiries |
LIFELONG LEARNING MANAGER
Eoin O’Brien BA, DBS, CBS, Cert Mgmt, MBA
E: eoin.obrien@itcarlow.ie |
| Course Web Page |
Web Page - Click Here |
| International Students |
Web Page - Click Here |
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