Short Title:Medical Device Manufacturing
Full Title:Medical Device Manufacturing
Language of Instruction:English
Module Code:MDMG H4000
 
Credits: 5
NFQ Level:8
Field of Study:Mechanics and metal work
Module Delivered in no programmes
Reviewed By:FIONA CRANLEY
Module Author:BRIAN O BRIEN
Module Description:The module aims to provide the student with a broad understanding of the manufacture of medical devices.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Describe the technical requirements and standards that apply to the use of cleanrooms used for the manufacture of medical devices.
LO2 Describe the cleaning and sterilisation processes relevant to various types of medical devices.
LO3 Outline the requirements of GMP systems and the operation of regulatory bodies such as FDA.
LO4 Describe the validation processes required for medical device design and m,anufacture.
LO5 Discuss the various types of packaging, closure systems and labelling relevant to medical device manufacture.
LO6 Describe and evaluate manufacturing processes key to medical device manufacturing, e.g. surface finishing, coating, co-extrusion etc.
Pre-requisite learning
Co-requisite Modules
No Co-requisite modules listed
 

Module Content & Assessment

Content (The percentage workload breakdown is inidcative and subject to change) %
Cleanroom Technology
Classifications, particle size & counting, filtration, design and layout, standards, cleanroom airflow, commissioning and qualification.
20.00%
Cleaning and Sterilisation
Cleaning requirements, cleaning systems and equipment. Sterilisation types, Ethylene Oxide, Gamma sterilisation, Electron Beam, dry heat. Modes and kinetics of microbial /endotoxin inactivation.
20.00%
Packaging
Function of packaging, packaging types and properties, sterilisation requirements, Labelling and packaging control. packaging manufacture, materials, methods, closure, testing and regulation.
20.00%
Regulatory Requirements
European Regulations, European Medical Devices Vigilance system, Global medical Devices Nomenclature system, Overview of 93/42/EEC Medical Device Directive, in-vitro diagnostic directive 98/79/EC, ISO 13485 US Perspective: Classification and Medwatch Regulatory Agencies: IMB, FDA, Medical and Healthcare Products Regulatory Agency (UK, Global Harmonisation Task Force(GHTF)
20.00%
Industry relevany manufacturing processes
Surface finishing, coating technology and processes, co-extrusion
20.00%
Assessment Breakdown%
Course Work30.00%
End of Module Formal Examination70.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Continuous Assessment Multi-choice 1,2,3,4,5 30.00 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 70.00 End-of-Semester
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.
Reassessment Description
Repeat examination and CA if required

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 2.00 Every Week 2.00
Lab Preparation for 1.00 Every Week 1.00
Independent Learning Self directed learning 4.00 Every Week 4.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class based instruction 2.00 Every Week 2.00
Lab Preparation for 1.00 Every Week 1.00
Independent Learning Self directed learning 4.00 Every Week 4.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
 

Module Resources

Required Book Resources
  • Hill, D. 1998, Design Engineering of Biomaterials for Medical Devices, Wiley
  • Domach, M. M. 2004, Introduction to Biomedical Engineering, Prentice Hall
Recommended Book Resources
  • Richard Fries 2012, Reliable Design of Medical Devices,, 3rd Ed., Ed., CRC Press [ISBN: 1439894910]
This module does not have any article/paper resources
This module does not have any other resources