Course Summary
This programme (SG_SMEDI_E08) 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, including Quality Management in a digital age and Quality 4.0. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits.
Programme Aims are:
- Provide participants with a fundamental grounding in medical device regulatory structures and requirements.
- Provide the training necessary to convert personnel employed in the Medical Technologies sector with life sciences qualifications (Level 6, Level 7, or Level 8) to transition into specialist roles in the medical technology quality assurance and/or regulatory affairs functions and to upskill medical technology professionals in the regulatory framework in their existing roles.
- Foster the participant’s intellectual development in academic and industrial environments.
- Develop participant's skills to work and communicate with appropriate autonomy and effectively through various media.
The programme objectives are:
- To produce graduates with the essential breadth and kind of knowledge, skills set and competencies required to function in specialist roles in the medical technology regulatory affairs function, to upskill medical technology professionals in the regulatory framework in their existing roles and to be capable of contribution to regulatory projects and projects with a regulatory element in a medical device company environment.
- To ensure that participants have sufficient skills and knowledge to employ a fundamental level of data analysing, sythesising, summarising and writing skills in a regulatory environment.
- To ensure that participants can communicate and defend scientific data and findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public.
- To ensure participants have the skills and ability to function within, and adapt to, a changing technical work environment and evolving regulatory frameworks.
- To ensure the participants can provide appropriate input and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world.
Course outline
The programme consists of a one year part-time Level 8 Certificate in Medical Technology Regulatory Affairs and Quality (30 credits). The programme shall be made available online using a combination of distance-learning / e-learning technologies and some face to face workshops for an overall blended learning approach. The educational elements will be provided by the ATU Sligo, and NUI Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners.
The programme consists of 6 modules, each worth 5 ECTS. The programme is delivered over two semesters (one academic year). Three modules are delivered per semester.
Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions.
Who teaches this course?
The programme will be delivered by academic staff from NUI Galway and ATU Sligo, with expertise in Regulatory Affairs, with guest lectures and workshops involving Regulatory Affairs experts from the Medical technology industry sector.
Progression
Students who successfully complete the Level 8 Certificate in MedTech Regulatory Affairs and Quality may progress onto a follow on Year 2 programme to obtain a Level 8 Higher Diploma award.
Entry Requirements
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 NUI Galway.
Career Opportunities
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.”
Senior business leaders were asked to identify the current number of employees required to meet their current skills demand, as well as the forecasted number of employees required in each function of their organisation up to 2020. An estimated 4,000 additional jobs are planned by 2020, Key areas are: Regulatory 54 additional jobs (43% increase from 2016) Quality 287 additional jobs (17% increase from 2016)1
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 20162 further supports this need as it identified a skills shortage for regulatory professionals and quality control engineers
1Source: Irish Medtech Association Skills Needs Assessment Stakeholder Survey. "Future skills needs analysis for the medical technology sector in Ireland to 2020"
Further Study
Following completion of the one year Level 8 Certificate in Medical Technology Regulatory Affairs and Quality (30 credits) students are eligible to continue for a second Year to complete a Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality (60 credits).
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 NUI Galway and ATU Sligo.
Did you know?
The course meets a skills gap as highlighted in the SOLAS “Difficult to fill vacancies” survey of 2021 where 46% of employers expressed difficulty in filling roles related to manufacturing processes, validation, quality and regulatory, as well as compliance and regulatory affairs specialists (SOLAS pdf). Future Skills gaps highlighted by the Irish Medtech Skillnet in 2020 highlighted manufacturing , quality and regulatory as areas of future skills shortages (Irish Medtech Pdf).
Alumni
A recent study by NUI Galway & ATU Sligo and published in Regulatory Focus found that our Medtech courses are valuable for CPD and upskilling within the industry as over 90% of students/graduates were promoted in their own organisations/moved to other positions while completing the course or after graduation Link to Recent Study.
Programme Fees
Academic Year 2024/25 Fees
Total Programme Fee: €4,500
Funding Opportunities
Next Level Skillnet funding may be available to successful applicants who fulfil eligibility criteria. Please email Sue Davies in Next Level Skillnet to find out more information: sue@nextlevel.ie
Next Level Skillnet Member - €1,350 per semester*
Fee Next Level Skillnet Non-Member Fee - €2,025 per semester**
* Subject to confirmation of funding support for each semester. See next level skillnet qualifying criteria at http://nextlevel.ie/at-a-glance/employee/
** Companies who do not qualify under the Next Level Skillnet criteria may still enrol on the course at the Non-Member rate by contacting Next Level Skillnet, sue@nextlevel.ie
Course Format
Semester 1
| Title | Credits |
|---|---|
| Introduction to Quality Management Systems | 05 |
| Fundamentals of EU Medical Device Regulations | 05 |
| Auditing and Compliance | 05 |
Semester 2
| Title | Credits |
|---|---|
| Fundamentals of US Medical Device Regulations | 05 |
| Risk Management and Design Control | 05 |
| Validation and Calibration | 05 |