Short Title:Medical Device Regulatory Affairs
Full Title:Medical Device Regulatory Affairs & Ethics
Language of Instruction:English
Module Code:RGAF H3000
 
Credits: 5
Field of Study:Engineering, Manufacturing and Construction
Module Delivered in 2 programme(s)
Reviewed By:FIONA CRANLEY
Module Author:ANTHONY TANSEY
Module Description:The module aims to provide the student with a broad understanding of the various regulatory requirements required for bringing a medical device to market. It will provide an overview of the medical device industry both globally and nationally, covering the European medical device directives and US codes of federal regulation, the national regulatory groups, and notified bodies, and the ethical codes associated with each region.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Describe the medical device industry, the principle regulatory authorities involved.
LO2 Describe the key principles associated with the control and regulation of the medical devices industry.
LO3 Describe specific standards and how they relate to the manufacture of bio-medical devices.
LO4 Describe the key aspects of ethical codes relating to medical devices
LO5 Relate the approvals process and ethical issues of medical device design to a non technical or multidisciplinary audience.
 

Module Content & Assessment

Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Continuous Assessment The students will be required to investigate the standards and legal requirements for a medical device. The output of this assignment will be a report on the regulatory requirements for the device which identifies the key stages for certification. 1,2,3,4,5 50.00 Ongoing
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,2,3,4,5 50.00 End-of-Semester

IT Tallaght reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class based instruction 3.00 Every Week 3.00
Lecturer Supervised Learning Application of course material 1.00 Every Week 1.00
Independent Learning Personal study. Research and investigation of related material. 4.00 Every Week 4.00
Total Weekly Learner Workload 8.00
Total Weekly Contact Hours 4.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class based instruction 3.00 Every Week 3.00
Lecturer Supervised Learning Application of course material 1.00 Every Week 1.00
Assignment Personal study. Research and investigation of related material. 4.00 Every Week 4.00
Total Weekly Learner Workload 8.00
Total Weekly Contact Hours 4.00
 

Module Resources

Recommended Book Resources
  • [editors] John D. Enderle, Susan M. Blanchard, and Joseph D. Bronzino 2011, Introduction to biomedical engineering, 3rd Ed., Elsevier Academic Press Amsterdam [ISBN: 978-01237497]
  • Seeram Ramakrishna 2015, Medical Devices: Regulations, Standards and Practices, 1st Ed., Woodhead Publishing Ltd [ISBN: 978-008100289]
  • Val Theisz 2015, Medical Device Regulatory Practices: An International Perspective, 1st Ed., Pan Stanford [ISBN: 978-981466910]
  • Mr D G Daugherty 2015, FDA Quality System Regulation for Medical Devices (21 CFR Part 820), CreateSpace Independent Publishing Platform [ISBN: 978-152284024]
This module does not have any article/paper resources
This module does not have any other resources
 

Module Delivered in

Programme Code Programme Semester Delivery
TA_EBIOM_B B.Eng (Hons) in Biomedical Design 5 Mandatory
TA_EBIOM_D Bachelor of Engineering in Biomedical Design 5 Mandatory