Medical Technology Regulatory Affairs & Operations - Online

Institute of Technology Sligo


Course Name Medical Technology Regulatory Affairs & Operations - Online
Course Provider Institute of Technology Sligo
Course Code 109118 (Assigned by Qualifax. Not an official code)
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 or Distance
Location (Districts) Ballinode
Enrolment and Start Dates Comment Contact the college for the next start date.
Application Date Application Closing Date: 31st August 2021.
Application Weblink Web Page - Click Here
Duration 1 year part-time online.
Course Fee Total Programme Fees: €4,500
Fees per annum: €4,500
Per 10 credit module: €1,800
Per 5 credit module: €900

Non-EU Fees
Non-EU Programme Fees: €8,000 per annum
Entry Requirements

Expand+Students who successfully complete the Level 8 Certificate in MedTech Regulatory Affairs and Operations may progress onto a follow on Year 2 programme to obtain a Level 8 Higher Diploma award (this can also be done by completing the other Level 8 Cer...

Course Content

Expand+Course Summary
This programme (SG_SMEDO_E08) has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles, introducing a focus on operations. The impetus for the developme...

Subjects Taught Semester 1
Fundamentals of Global Medical Device Regulations 05
Sterilisation and Biocompatability 05
Operations Management and GMP 05

Semester 2
Fundamentals of Medical Device Clinical Trials 05
Introduction to Market Vigilance and Labelling 05
Technical Report Writing 05
Number of Credits 30
Careers or Further Progression

Expand+Career Opportunities
This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs or Quality environment within the highly successful and growing Irish Medical Technology industry sector.

The Level 8 Hig...

Further Enquiries Admissions Office
T: 353 (0) 71 931 8510
Course Web Page Web Page - Click Here