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 Medical Technology Regulatory Affairs and Quality programme from Institute of Technology Sligo 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.
This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs or Quality environment within the highly successful and growing Irish Medical Technology industry sector.
The Level 8 Higher Diploma and 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 in conjunction with a taskforce comprised of regulatory experts from industry, industry practitioners and representatives from the regional skills for a west and north west.
- Introduction to Quality Management Systems
- Fundamentals of EU Medical Device Regulations
- Auditing and Compliance
- Fundamentals of US Medical Device Regulations
- Risk Management and Design Control
- Validation and Calibration
We are not aware of any academic requirements for this programme.
- 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.
International6000 EUR/yearTuition FeeBased on the tuition of 12000 EUR for the full programme during 24 months.
EU/EEA2250 EUR/yearTuition FeeBased on the tuition of 4500 EUR for the full programme during 24 months.
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Due for update
Updated over a year ago
Check the official programme website for potential updates.