Medical Technologies Regulatory Affairs & Quality

Course Overview

The Level 8 Certificate in Medical Technologies Regulatory Affairs and Quality provides students with an introduction to the core elements of the product development lifecycle and the associated role of a Medical Technology Regulatory Affairs and/or Quality professional. The programme ensures that students acquire a good, fundamental understanding of all applicable regulations and skills to address the ever-changing environment of Medical Technologies Regulatory Affairs and Quality.



The Level 8 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 jointly by University of Galway and IT Sligo, in conjunction with 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 link the existing regulations to regulatory requirements and how those requirements are executed across the medical device lifecycle, for example; how to develop technical documentation for regulatory submissions (regulatory affairs professionals), how to perform vigilance post market surveillance requirements (Vigilance specialist), core quality management standards and requirements (QA or Compliance Specialist) and testing requirements to demonstrate safety and efficacy of a medical device (R&D Engineer).



Course Outline

- The Level 8 Certificate in Medical Technology Regulatory Affairs and Quality is a one year part-time programme (30 credits). The programme is made available online using a combination of distance-learning / e-learning technologies, with some optional workshops. The educational elements are provided by University of Galway and Institute of Technology Sligo staff. Additional lecturing, as required, may be provided by industry specialists and practitioners.



- The programme consists of six modules, each worth 5 ECTS. The programme is delivered over two semesters (one academic year). Three modules are delivered per semester.



- Assessment of students is through continuous assessment of each module, including written assignments, e-tivities, problem solving, and online open-book exams using multiple choices, matching questions as well as short and long answer questions



- The Certificate programme is also available for students to undertake in a modular format, enabling students to select any individual module or combination of modules in any year, up to a maximum of 3 modules per semester



- Students undertaking the modular programme can select any individual module or combination of modules from the six modules in one year. Students must complete all 6 modules within six years, to obtain a Level 8 certificate award.



- The programme is being 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 is provided by the Institute of Technology, Sligo, and University of Galway staff. Additional lecturing, as required, may be provided by industry specialists and practitioners.

Semester 1 modules (each module is 5 ECTS)

Introduction to Quality Management Systems

Fundamentals of EU Medical Device Regulations

Auditing and Compliance



Semester 2 modules (each module is 5 ECTS)

Fundamentals of US Medical Device Regulations

Risk Assessment

Validation and Calibration



Year 1 (30 Credits)

Required MTR1105: Risk Assessment

Required MTR1102: Fundamentals of EU Medical Device Regulations

Required MTR1103: Auditing and Compliance

Required MTR1101: Introduction to Quality Management Systems

Required MTR1106: Validation and Calibration

Required MTR1104: Fundamentals of US Medical Device Regulations

Students with a Level 7 or higher qualification in science or engineering are eligible for this Level 8 programme. Students with a Level 7 or higher qualification in a non-technical subject area but who hold a minimum of two years’ relevant medtech industrial experience in regulatory affairs or quality are also eligible to apply.

IMPORTANT: to find out how to apply for the course please contact butler.mary@itsligo.ie or olivia.mcdermott@universityofgalway.ie.



How to apply

We encourage all applicants to apply as early as possible.



Review/Closing Dates (for Taught Programmes)

For most programmes, University of Galway does not set specific closing dates for receipt of applications. Applications will be accepted on a rolling basis and course quotas will be reviewed continuously throughout the application cycle with the exception of applications for some programmes which are reviewed after the specified closing date. Candidates who do not have their final degree marks available may be made a conditional (provisional) offer.



Online Application

Applications to most postgraduate programmes at University of Galway are made online via www.universityofgalway.ie/apply (see "Application Weblink").

1 year (2 semesters), part-time distance learning (100% online).

Next start date: September 2024.



Review/Closing Dates (for Taught Programmes)

For most programmes, University of Galway does not set specific closing dates for receipt of applications. Applications will be accepted on a rolling basis and course quotas will be reviewed continuously throughout the application cycle with the exception of applications for some programmes which are reviewed after the specifed closing date*. Candidates who do not have their final degree marks available may be made a conditional (provisional) offer.

Career Opportunities

The Irish Medtech Association (IMA) Skillnet asked senior medtech industry executives to identify the current number of employees required to meet current skills demand, and to forecast the number of employees required in medtech organisations up to 2020. The IMA report has estimated that 4,000 additional medical technologies jobs will be added by 2020, with a 43% increase in staff numbers in the regulatory affairs functions and 17% in quality roles.



Further Education

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). The Higher Diploma award ewill be available from September 2018.



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 University of Galway and IT Sligo.