Medical Technology Regulatory Affairs & Quality - Online
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 IT 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.
Programme objectives 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.
The programme consists of a two year part-time Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality (60 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 Institute of Technology Sligo, and NUI Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners.
The programme consists of 12 modules, each worth 5 ECTS. The programme is delivered over four semesters (two academic years). Three modules are delivered per semester.
Who teaches this course?
The programme will be delivered by academic staff from NUI Galway and IT Sligo, with expertise in Regulatory Affairs & Quality, with guest lectures and workshops involving Regulatory Affairs/Quality experts from the Medical technology industry sector.
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 IT Sligo and NUI Galway.
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.
Introduction to Quality Management Systems 05
Fundamentals of EU Medical Device Regulations 05
Auditing and Compliance 05
Fundamentals of US Medical Device Regulations 05
Risk Management and Design Control 05
Validation and Calibration 05
Fundamentals of Global Medical Device Regulations 05
Sterilisation and Biocompatability 05
Operations Management and GMP 05
Fundamentals of Medical Device Clinical Trials 05
Introduction to Market Vigilance and Labelling 05
Technical Report Writing 05
2 years part-time online.
€4,500 per annum
or €9,000 total.
€900 per module.
Non-EU total fees: €12,000
Next Level Skillnet Member - €1,417.50 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, email@example.com
Contact the college for the next start date.
Post Course Info
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 2016 further supports this need as it identified a skills shortage for regulatory professionals and quality control engineers.
1 Source: Irish Medtech Association Skills Needs Assessment Stakeholder Survey. "Future skills needs analysis for the medical technology sector in Ireland to 2020"?
Students who successfully complete the Level 8 Certificate in MedTech Regulatory Affairs and Operations may progress onto a follow on Year 2 programme to obtain a Level 8 Higher Diploma award (this can also be done by completing the other Level 8 Certificate in MedTech Regulatory Affairs and Quality).