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The Level 8 Certificate in Medical Technologies Regulatory Affairs and Operations has been specifically designed to meet the growing requirements of medical technology companies in filling regulatory and quality assurance roles, introducing a focus on operations. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by University of Galway and IT Sligo, in conjunction with selected external professionals, including regulatory experts from industry, 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 links 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 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 Cert programme, participants receive an NFQ Level 8 award of 30 credits.

The course 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, introducing a focus on Operations. 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 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:

• 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.

Programme objectives:

• 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, synthesising, summarising and writing skills in a regulatory environment.