Medical Technology Regulatory Affairs and Quality (Cert)

Get the Edge with a Postgraduate Degree from NUI Galway Grainne McNamara - MSc Enterprise Systems Gordan Sands - MSc Medical Physics Biomedical Engineering at NUI Galway Mohammed Hasan – Occupational Health & Safety (MSc)

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). 

 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

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.

The course will enable Regulatory Affairs and Quality Assurance 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 Assurance. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits.

Fees information

The Level 8 Certificate was approved as a Higher Education Authority Springboard course in 2020. 

Springboard Fees: €3,500; government-funded for those classified as unemployed

€350 (10%) Fee for employed participants

To apply for the Certificate through Springboard please go to https://springboardcourses.ie/details/8169

Modular Fee EU:€900 per module

Note: In order to be eligible for EU (as opposed to the higher Non EU) fee rates, applicants must qualify through Nationality or Residency N.B. Eligibility for EU fee rates does NOT confer entitlement to ’free fees’. Note in particular the provisions regarding eligibility under: (1) Nationality and (2) Residence.  For further information visit http://www.nuigalway.ie/student-fees/international/

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You may also be interested in one of our other Life and Biomedical Sciences postgraduate programmes.

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Key Facts

Entry Requirements

Additional Requirements

Recognition of Prior Learning (RPL)

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)

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

 Semester 2 modules (each module is 5 ECTS)

4. Fundamentals of US Medical Device Regulations
5. Risk Assessment
6. Validation and Calibration

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.

Why Choose This Course?

Career Opportunities

Who’s Suited to This Course

Learning Outcomes

Transferable Skills Employers Value

Work Placement

Study Abroad

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Course Fees

Fees: EU

Fees: Tuition

Fees: Student levy

Fees: Non EU

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