Certificate (Medical Technology Regulatory Affairs & Quality (online)
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 NUI 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)
- 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.
The programme consists of six modules, each worth 5 ECTS. The programme is delivered over two semesters (one academic year). Three modules are delivered per semester.
The Certificate programme is also available for students to undertake in a modular format, enabling students to select any individual module or combination of modules in any year, up to a maximum of 3 modules per semester
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 6 modules within six years, to obtain a Level 8 certificate award.
Semester 1 modules (each module is 5 ECTS)
- Introduction to Quality Management Systems
- Fundamentals of EU Medical Device Regulations
- Auditing and Compliance
Semester 2 modules (each module is 5 ECTS)
- Fundamentals of US Medical Device Regulations
- Risk Assessment
- Validation and Calibration
