Medical Technology Regulatory Affairs & Quality - Sligo
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.
Subjects taught
Modules
Introduction to Quality Management Systems
Fundamentals of EU Medical Device Regulations
Auditing and Compliance
Fundamentals of US Medical Device Regulations
Risk Management and Design Control
Validation and Calibration
Fundamentals of Global Medical Device Regulations
Sterilisation and Biocompatibility
Operations Management and GMP
Fundamentals of Medical Device Clinical Trials
Introduction to Market Vigilance and Labelling
Technical Report Writing
Entry requirements
Level 7 qualification in a relevant area of Science, Engineering or Technology.
Assessment Info
Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions.
Credits
60
Duration
2 years part-time, online.
On-Campus Attendance
One optional workshop each year which is an opportunity to meet lecturers and network with other students.
Fees
€4,500 per annum
or €9,000 total.
€900 per module.
Non-EU total fees: €12,000
Next Level Skillnet Member - €1,417.50 per semester*
Fee Next Level Skillnet Non-Member Fee - €2,025 per semester**
* Subject to confirmation of funding support for each semester. See next level skillnet qualifying criteria at http://nextlevel.ie/at-a-glance/employee/
** Companies who do not qualify under the Next Level Skillnet criteria may still enrol on the course at the Non-Member rate by contacting Next Level Skillnet, sue@nextlevel.ie