Medical Technology Regulatory Affairs & Quality - Online

Institute of Technology Sligo


Course Name Medical Technology Regulatory Affairs & Quality - Online
Course Provider Institute of Technology Sligo
Course Code SG_SMEDI_E08
Course Type Lifelong Learning
Award NameNFQ ClassificationAwarding BodyNFQ Level
Special Purpose Certificate (Level 8 NFQ)  More info... Special Purpose Institute of Technology Sligo Level 8 NFQ
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Attendance Options Part time, Online
Location (Districts) Ballinode
Enrolment and Start Dates Comment Contact the college for the next start date.
Application Date Application Closing Date: 30 August 2019.
Application Weblink Web Page - Click Here
Course Fee

Expand+Total €4,500

Per Module : €900

Non EU fees: €8000 for certificate

Next Level Skillnet Member - €1,350 per semester*

Fee Next Level Skillnet Non-Member Fee - €2,025 per semester**

Springboard Fees
Fee €3,500

FREE for tho...

Entry Requirements

Expand+Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme. Applications from candidates who hold a Level 7 primary degree in a non-technical subject, and who have at l...

Course Content

Expand+This programme (SG_SMEDI_E08) has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from indust...

Subjects Taught Semester 1 Title Credits
Introduction to Quality Management Systems [E] 05
Fundamentals of EU Medical Device Regulations [E] 05
Auditing and Compliance [E] 05

Semester 2 Title Credits
Fundamentals of US Medical Device Regulations [E] 05
Risk Assessment [E] 05
Validation and Calibration [E] 05

[E] = Elective Module. Modules subject to availability.
Assessment Method 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.
Number of Credits 30
Careers or Further Progression

Students who successfully complete the Level 8 Certificate in MedTech Regulatory Affairs and Quality may progress onto a follow on Year 2 programme to obtain a Level 8 Higher Diploma award.

This programme will equip graduates with ess...

Further Enquiries Further Information:
tel: 071 9318511

Prof. Terry Smith
T: 353 91 492 022

Ms Mary Butler
Institute of Technology, Sligo
Course Web Page Web Page - Click Here