Medical Technologies Regulatory Affairs and Operations (Online)

Course Overview

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.
• 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.
  
  

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Key Facts

Entry Requirements

Additional Requirements

Recognition of Prior Learning (RPL)

Course Outline

The Level 8 Certificate in Medical Technology Regulatory Affairs and Operations programme is a one year part-time 30 ECTS course, delivered over two Semesters from September–May each year. The programme is made available online using distance-learning / e-learning technologies, with one optional workshop. The educational elements are provided by University of Galway and Institute of Technology Sligo staff. Additional lecturing, as required, may be provided by industry specialists and practitioners. The course consists of 6 modules, with 3 modules delivered per semester. Students undertaking the Certificate must complete all 6 taught modules, to obtain Level 8 Cert award. Assessment of students is through continuous assessment of each module, including written assignments, open-book exams using multiple choices, matching questions as well as short and long answer questions, and workshop-based problem-solving. Assessment of students is through continuous assessment of each module, including written assignments, e-tivities, problem solving, and online open-book exams using multiple choices, matching questions as well as short and long answer questions.

Semester 1 Modules (each module is 5 ECTS)

1. Fundamentals of Global Medical Device Regulations.
2. Sterilisation & Biocompatability.
3. Operations Management and GMP.

Semester 2 Modules (each module is 5 ECTS)

1. Fundamentals of Medical Device Clinical Trials.
2. Introduction to Market Vigilance & Labelling.
3. Technical Report Writing.

On successful completion of this programme graduates will:

• Have a general knowledge and understanding of the theory and best practice relating to medical device regulatory structures and procedures.
• Demonstrate a general knowledge and understanding of current medical device global regulations and the role of the regulatory affairs professional and quality assurance personnel in the industry.
• Be able to employ appropriate fundamental level of data analysing, synthesising, summarising and writing skills to evaluate aspects of regulatory affairs and quality/operations indicators within medical technology industry.
• Communicate and defend scientific and quality information/regulatory findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public.
• Appreciate the complex and fluid relationships of medical technology processes, prescribed regulatory framework and selected support activities.
• Apply concepts and skills learnt in a variety of contexts.
• Work effectively in a medical technology environment by: acting autonomously and thinking independently to meet regulations, or by participating constructively in a team environment within a technical field, to ensure the team is operating within the appropriate regulations.

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Further Education

Following completion of the one year Level 8 Certificate in Medical Technology Regulatory Affairs and Quality (30 credits) students are eligible to continue for a second Year to complete a Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality (60 credits). 

Graduates with the Higher Diploma award will be eligible to apply to undertake the MSc. in Medical Technologies Regulatory Affairs, a part-time distance learning Level 9 programme jointly delivered by University of Galway and IT Sligo.

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Course Fees

Fees: EU

Fees: Tuition

Fees: Student levy

Fees: Non EU

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