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Medical Technology Regulatory Affairs and Quality (Cert)
IMPORTANT: to find out how to apply for the course
please contact email@example.com or firstname.lastname@example.org
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 NUI 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.
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/
Applications and Selections
To apply for this programme please complete all of the steps below:
Step 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.
Step 2: Have all of the supporting documentation in place
Visit our Supporting Documents website for document requirements for this course.
Step 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. NOTE: Language tests must be undertaken no more than two years prior to commencement of your programme at the University.
The NUI Galway TOEFL institution code is 8861.
Any application queries should be emailed to email@example.com
Who Teaches this Course
The programme will be delivered by academic staff from NUI Galway and IT 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.
The staff associated with the programme development and delivery include:
- Professor Terry Smith (NUI Galway)—Co-Director
- Ms Mary Butler (IT Sligo)—Co-Director
- Ms Deidre Barrow (Med Tech Regulatory Affairs Consultant)—Lecturer
- Dr Olivia McDermott (NUI Galway)— Lecturer
- Dr Sandra Ganly (NUI Galway)—Lecturer
- Dr Stephen Daly (IT Sligo)—Lecturer
- Dr Ailish Breen (IT Sligo)—Lecturer
- Dr Mary Garvey (IT Sligo)—Lecturer
- Dr Yvonne Lang (IT Sligo) – Lecturer
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.
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.
1 year part-time online course
Next start date
A Level Grades ()
QQI/FET FETAC Entry Routes
15 August 2021
Mode of study
- 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 NUI 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 NUI 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
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 NUI Galway and IT Sligo.
Why Choose This Course?
This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs environment within the global Medical Technology industry sector. It 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 and industry practitioners.
Regulatory Affairs within the medical technology products sector is a relatively young, multidimensional profession that is international in scope. Operationally, a Regulatory Affairs professional is responsible for ensuring that pertinent government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and health care system. Given the evolving nature of international regulations, a regulatory affairs professional must continually grow their knowledge and skills to be effective and to advance in their careers.
Regulatory professionals at all career and experience levels are involved in activities throughout the product lifecycle, and are involved to some degree in bridging the gap between regulatory-related functions and organisation and business activities.
The Irish MedTech Association (IMA) asked senior MedTech industry executives to identify the current number of employees required to meet current skills demand, as well as forecasted number of employees required in MedTech organisations up to 2020. The IMA report (2017) 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. Over 30,000 people are employed in the highly successful and growing Irish Medical Technology industry sector, representing one of the leading global hubs of MedTech industries.
Who’s Suited to This Course
Related Student Organisations
Fees: Student levy
Fees: Non EU
Modular Fee EU:€900 per module—2020/21
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