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.

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

Level 7 qualification in a relevant area of Science, Engineering or Technology.

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.

60

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.

€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