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 ATU 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. 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. Course outline: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 ATU Sligo, and University of 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. 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. Who teaches this course?The programme will be delivered by academic staff from University of Galway and ATU Sligo, with expertise in Regulatory Affairs & Quality, with guest lectures and workshops involving Regulatory Affairs/Quality experts from the Medical technology industry sector.
| Course Category | Technology, Science & Technology |
| Course Type | Online Learning |
| Course Qualification | Higher Diploma |
| Course Start Date | 1st January 1970 |
| Course Duration | 2 years |
| Course Time | Part-time |
| Course Fee | 9000 |
| Entry Requirements | 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 ATU Sligo and University of Galway. |
| Career Path | Graduates of this programme will have a qualification in Medical Science. The programme has been designed so that it will meet the requirements for approval by the state registration body, CORU. Therefore, graduates of the programme will be eligible to work as medical scientists. |
This course is free/ funded under the Springboard+ Initiative.
Newly updated 60ECT Programme! The Professional Diploma in Education Home Economics (PDEHE) programme provides an opportunity for registered teachers of other subjects who have an interest in and passion for Home Economics, to acquire the knowledge, attitudes, and practical skills required to teach Home Economics at post primary level.
This programme has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles.
This programme is run in conjunction with NIBRT (National Institute for Biopharmaceutical Research and Training), with many of the lecturers and guest lecturers from NIBRT.
