The Level 8 Higher Diploma 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 Higher Diploma 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). 

 

Regulatory Affairs and Quality personnel within the medical technology products sector are responsible for assuring that pertinent government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and healthcare system.  Given the evolving nature of international regulations regulatory affairs and quality assurance professionals must continually grow their knowledge and skills to be effective and to advance in their careers. This course will ensure the development and enhancement of those skills.