Short Title:Medical Device Operations
Full Title:Medical Device Operations
Language of Instruction:English
Module Code:MDOP H1004
 
Credits: 5
Field of Study:Biology and biochemistry
Module Delivered in 1 programme(s)
Reviewed By:JOHN BEHAN
Module Author:ED CAREY
Module Description:This module aims to provide the student with: 1. Overview of Medical Device Regulations 2. Overview of the processes of medical device design and development 3. Understanding of Medical Device Technologies 4. Understanding of Packaging and Sterilisation Controls
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Lead projects within the medical device sector
LO2 Advice on best practice medical device technologies
LO3 Operate within quality, manufacturing, engineering functions within a medical device company
 

Module Content & Assessment

No Course Work
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination   70.00 End-of-Semester

TU Dublin – Tallaght Campus reserves the right to alter the nature and timings of assessment

 

Module Workload

This module has no Full Time workload.
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture weekly lectures 2.00 Every Week 2.00
Total Weekly Learner Workload 2.00
Total Weekly Contact Hours 2.00
 

Module Resources

This module does not have any book resources
This module does not have any article/paper resources
Other Resources
  • ISO 1464: Clean room classification
  • 21 CFR Part 820: FDAQuality System Regulation Overview
  • ISO 13485:2003: Medical Device Quality Management System Requirements for Regulatory Purposes Overview
  • 93/42 EEC: Medical Device Directive
  • SOR/98-282: Medical Device Regulations overview
 

Module Delivered in

Programme Code Programme Semester Delivery
TA_SSPPM_B Certificate in Pharmaceutical and Medical Device Manufacturing (Special Purpose Award)v2 1 Mandatory