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Institution / Institute of Technology Carlow Carlow Campus
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Medical Device regulatory Affairs

What is the programme about?
This Master of Science in Medical Device Regulatory Affairs presents students with the opportunity to 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 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 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.

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.

Duration

2 years, part-time (2 evenings per week 7 - 10pm)

Careers or further progression

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. 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’.

Further enquiries

Lifelong Learning Centre
Institute of Technology Carlow,
Kilkenny Road,
Carlow.
Tel: 059 9175280
Fax: 059 9175005
Email: lll@itcarlow.ie
Web: www.itcarlow.ie/lll

Subjects taught

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

Comment

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).

Students taking Level 6, 7 or 8 courses of 1 year duration or longer where course fees are €2,290 and who opt to pay full course fees by Saturday 2nd September 2017 will be eligible to benefit from the €300 discounted fee of €1,990.

For programmes where fees exceed €2,290 the appropriate fee payment regulation information is available from the faculty for Lifelong Learning.

(a) Course fees are expected to be paid in full at the commencement of the course. IT Carlow recognises that some students may have difficulties in paying the full amount in one transaction thus the Lifelong Learning Centre has created a number of fee payment by instalment options. All such applications will be treated in confidence. In general, fee payment by instalment applications will only be considered for fees in excess of €1,000.
Students who apply for and are granted a fee payment by installment plan should note that failure to meet the payment dates set down for their payment scheme, in particular key dates, may:
• be denied access to Blackboard
• be prevented from sitting examinations in December, May or August as applicable
• have all other assignment / exam results withheld until payments are made
• assignments will not be accepted nor will a late submission for an assignment be accepted after late payments are made
• pay an additional surcharge.

(b) Students in receipt of employer sponsorship etc. will be required to submit a letter of confirmation of commitment to pay from their employer of funding body. They must also include a Purchase Order Number for invoice purposes. Where fees have not been paid by the ‘sponsor’ within thirty days after issue of the invoice, it is the responsibility of the student to then pay the fee and claim back fees from their sponsor.

(c) Repeat students will be required to pay relevant examination fee when applying to sit the repeat.

(d) The Faculty for Lifelong Learning has a strict policy in relation to Refund of Course Fees and a fees refund or a percentage of same will only be given in the following circumstances:
• A full refund will be given if requested in writing before the commencement of the course.
• Where a student leaves within two weeks of the start of a short course (10-13 weeks), 70% refund of the course fee will apply. Outside this two week period there will be no refund of fees.
• For long courses i.e. those of one-year duration or longer, a percentage of fees refund will be given over the first nine weeks of the course as per table 1. Thereafter there will be no refund of fees.
• The refund calculation is based on the full fee for the course not the amount that a student may have paid under a fees payment installment agreement.
• The fees refund calculation is based on the date that the student formally applies in writing to withdraw from the course.
• All courses will run subject to sufficient numbers. Where a course has to be cancelled those students who have registered and paid will be refunded in full.
• Receipts must be retained and produced when requesting a refund of course fees which must be applied for on the official refund form.

Application date

Closing Date for Applications

All Postgraduate Applications – 12 noon 14th August 2017

All other applications – 12 noon Friday 25th August 2017

Course fee

€7,400

Enrolment and start dates

Registration / Orientation Saturday 2nd September 2017

Courses Commence
Monday 11th September 2017

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