Duration:           1 Year Part-Time

Commences:     September 2017

*Cost:                   Per Semester**Members: €1,350   Non-Members: €2,025

*   Subject to confirmation of funding support for semester 2

**Please Note
To qualify for ulearning Skillnet membership an employer must be a private sector company and must be either paying their employees fees directly or if employee is paying the fees themselves they must be being reimbursed by their employer. Companies who do not qualify under these criteria may still enrol on the course at the Non-Member rate by contacting ulearning Skillnet.

For further details please contact Sue on 061 363 418 or email info@ulearning.ie 

ulearning Skillnet are delighted to announce funding for a new on-line Certificate in Medical Technology Regulatory Affairs and Quality programme.  The programme which is jointly delivered by IT Sligo and NUI Galway 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. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits.

Programme Aims 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, synthesizing, 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.

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 IT Sligo and NUI Galway.

Course outline

The programme consists of a one year part-time Level 8 Certificate in Medical Technology Regulatory Affairs and Quality (30 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 6 modules, each worth 5 ECTS. The programme is delivered over two semesters (one academic year). 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.

Full details of the course can be found here

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