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 IT 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.
Programme objectives are:
•Provide participants with a fundamental grounding in medical device regulatory structures and requirements.
•Provide the training necessary to convert personnel employed in the Medical Technologies sector with life sciences qualifications (Level 6, Level 7, or Level 8) to transition into specialist roles in the medical technology quality assurance and/or regulatory affairs functions and to upskill medical technology professionals in the regulatory framework in their existing roles.
•Foster the participant's intellectual development in academic and industrial environments.
•Develop participant's skills to work and communicate with appropriate autonomy and effectively through various media.
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.
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 the Institute of Technology Sligo, and NUI 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 NUI Galway and IT Sligo, with expertise in Regulatory Affairs & Quality, with guest lectures and workshops involving Regulatory Affairs/Quality experts from the Medical technology industry sector.