The University of Galway, also known as National University of Ireland Galway (NUIG), is a public research university located in Galway, Ireland. It was founded in 1845 as Queen's College, Galway, and became a constituent college of the National University of Ireland in 1908.

The university offers a wide range of undergraduate and postgraduate programs across various disciplines, including arts, business, law, medicine, engineering, and science. NUIG is known for its strengths in research, particularly in the areas of biomedicine, environmental science, and human rights.

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The Level 8 Certificate in Medical Technologies Regulatory Affairs and Quality 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. 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 Level 8 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 jointly by University of Galway and IT Sligo, in conjunction with 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 link 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 programme aims are to: Provide participants with a fundamental grounding in medical device regulatory and quality requirements. Provide necessary training to convert personnel with life sciences qualifications to transition into specialist roles in medical technology quality assurance and/or regulatory affairs functions and upskill medical technology professionals in the regulatory framework in their existing roles. Foster participants’ intellectual development and develop skills to work and communicate effectively through various media The Certificate course is also available for students to undertake in a modular format. Students undertaking the modular programme can select any individual module or combination of modules from the six modules in one year. Students must complete all six modules within six years, to obtain a Level 8 certificate award. The course will enable Regulatory Affairs and Quality Assurance 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 Assurance. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits. Show less

The National University of Ireland Galway, commonly known as University of Galway or simply NUI Galway, is a public research university located in Galway, Ireland. It was founded in 1845 as Queen's College Galway and became a university in 1908. NUI Galway is one of Ireland's leading universities, with a strong focus on research and innovation, and a reputation for excellence in teaching and learning. The university has five colleges - Arts, Social Sciences, and Celtic Studies; Business, Public Policy and Law; Engineering and Informatics; Medicine, Nursing and Health Sciences; and Science. NUI Galway offers undergraduate and graduate degree programs in a wide range of disciplines, including humanities, social sciences, science and technology, medicine, nursing, and business. NUI Galway is known for its research excellence, with particular strengths in areas such as biomedical science, environmental science, humanities and social sciences, and information technology. The university has several research institutes and centers focused on these areas, and has established partnerships with leading research institutions around the world. The university is located on a beautiful campus on the banks of the River Corrib, just a short walk from the vibrant city center of Galway. With its lively cultural scene, excellent restaurants and pubs, and easy access to the stunning natural beauty of the west coast of Ireland, Galway is a popular destination for students from around the world.

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