Program Overview

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Medical Technology Regulatory Affairs and Quality (Cert)

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.

Course Overview

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 ATU 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.

Programme Aims

The programme aims are to:

• Provide participants with a fundamental grounding in medical device regulatory and quality requirements.
• Provide necessary training to convert personnel with life sciences qualifications to transition into specialist roles in medical technology quality assurance and/or regulatory affairs functions and upskill medical technology professionals in the regulatory framework in their existing roles.
• Foster participants' intellectual development and develop skills to work and communicate effectively through various media.

Course Structure

The Certificate course is also available for students to undertake in a modular format. 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 six modules within six years to obtain a Level 8 certificate award.

Fees Information

• The Level 8 Certificate was approved as a Higher Education Authority Springboard course in 2025.
• Springboard Fees: 3,500; government-funded for those classified as unemployed.
• 350 (10%) Fee for employed participants.
• Modular Fee EU: 900 per module.

Applications and Selections

To find out more information on the course, please note the following steps:

1. Ensure you are eligible - entry criteria:
   • Students with a Level 7 or higher qualification in Science or Engineering are eligible for the proposed Level 8 programme.
   • Students with a Level 7 or higher qualification in a non-technical subject area but who hold a minimum of 5 years relevant medtech industrial experience in regulatory affairs or quality are eligible for the Level 8 programme.
2. Have all of the supporting documentation in place.
3. Ensure that you meet the English Language requirements:
   • All applicants, whose first language is not English must present one of the following qualifications in the English language and have no less than 6.5 in ANY component.
   • IELTS | TOEFL | Pearson PTE
   • 6.5 | 88 | 61

Who Teaches This Course

The programme will be delivered by academic staff from University of Galway and ATU Sligo, with expertise in Regulatory Affairs and Quality, with guest lectures and workshops involving Regulatory Affairs experts and practitioners from the Medical technology industry sector.

Requirements and Assessment

Assessment of students will be through continuous assessment of each module, which will include written assignments, team-based assignments, and open-book exams using multiple choices, matching questions as well as short and long answer questions.

Key Facts

Entry Requirements

• 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.

Additional Requirements

• Recognition of Prior Learning (RPL)

Duration

• 1 academic year (2 semesters, Late September-mid May), part-time distance learning (100% online)

Next Start Date

• September 2026

Average Intake

• 40

QQI/FET FETAC Entry Routes

• None specified

Closing Date

• No set closing date. Offers made on a continuous basis.

NFQ Level

• 8

Mode of Study

• Online Learning

ECTS Weighting

• 30

Award

• Level 8 Certificate

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 Atlantic Technological University Sligo staff. Additional lecturing, as required, may be provided by industry specialists and practitioners.

Semester 1 Modules

1. Introduction to Quality Management Systems
2. Fundamentals of EU Medical Device Regulations
3. Auditing and Compliance

Semester 2 Modules

1. Fundamentals of US Medical Device Regulations
2. Risk Assessment
3. Validation and Calibration

Curriculum Information

Module Details

MTR1101: Introduction to Quality Management Systems

This module aims to provide students with an introduction to Quality Management and an understanding of setting up a basic QMS and its implementation.

MTR1102: Fundamentals of EU Medical Device Regulations

This module aims to provide students with an introduction to and a fundamental understanding of current and upcoming EU legislation as it applies to medical devices.

MTR1103: Auditing and Compliance

This module introduces the regulatory requirement for GMP & compliance auditing, its benefits to an organisation, and the tools required by an effective auditor.

MTR1104: Fundamentals of US Medical Device Regulations

This module aims to provide students with an introduction to and a fundamental understanding of current US legislation as it applies to medical devices.

MTR1105: Risk Assessment

This module will enable students to understand the role of Risk assessment through the design process and product lifecycle.

MTR1106: Validation and Calibration

This module introduces the regulatory requirement for calibration and validation within a GMP environment, their benefits to an organisation, and the tools required for effective implementation.

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).

Why Choose This Course?

Career Opportunities

This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs environment within the global Medical Technology industry sector.

Who's Suited to This Course

The course is suited to individuals with a background in science, engineering, or a related field, looking to transition into regulatory affairs or quality assurance roles within the medical technology industry.

Learning Outcomes

Upon completion of the course, students will have a fundamental understanding of medical device regulatory and quality requirements, and the skills to work effectively in a regulatory affairs environment.

Transferable Skills Employers Value

The course will equip students with transferable skills, including communication, problem-solving, and teamwork, which are highly valued by employers in the medical technology industry.

Course Fees

Fees: EU

4,890 p.a. (including levy) 2026/27

Fees: Tuition

4,820 p.a. 2026/27

Fees: Student Levy

70 p.a. 2026/27

Fees: Non-EU

Not specified