Module Details

Module Code: LAWS C3603
Module Title: Medical Device Standards and Regulations
Title: Medical Device Standards and Regulations
Module Level:: 7
Credits:: 5
Module Coordinator: Cathal Nolan
Module Author:: Darren Kavanagh
Domains:  
Module Description: The aim of this module is to provide the student with knowledge and understanding in relation to the regulations, standards and practices of medical devices from an international perspective. The module focuses on the general regulations of medical devices, quality management systems, the approval process for different jurisdictions, risk assessment management, safety and clinical testing approaches, and finally, product development methodologies for medical devices.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Discuss the general regulations of medical devices.
LO2 Examine the quality management systems for medical device manufacture.
LO3 Compare the approval process for new medical devices in different jurisdictions.
LO4 Interpret risk assessment management, safety and clinical testing approaches for new medical devices.
LO5 Evaluate the product development methodologies for medical devices.
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is recommended before enrolment in this module.
No recommendations listed
Co-requisite Modules
No Co-requisite modules listed
Additional Requisite Information
No Co Requisites listed
 
Indicative Content
Introduction:
(i) Medical devices: definitions and types (ii) market trend (iii) general regulations, and (iv) background to the switch from Medical Device Directives (MDD) for Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR).
Quality Management Systems:
(i) Manufacturing practice for excellence (ii) ISO 13485 (iii) comparison of ISO and cGMP, and (iv) FDA CFR820.
Approval Process for New Medical Devices:
(i) European Union (ii) the United States (iii) China, and (iv) other jurisdictions.
Risk Assessment Management:
(i) Risk analysis and techniques (ii) risk acceptability, and (iii) risk management reporting.
Safety Testing:
(i) Absence of toxic substance (ii) biocompatibility tests (iii) cytotoxicity, sensitization, and irritation (iv) Acute (Systematic), subacute, subchronic, and chronic toxicity (v) genotoxicity, carcinogenicity, and reproductive and development toxicity (vi) implantation (vii) hemocompatibility (viii) biodegradation (ix) sterility tests (x) transportation tests (xi) electrical tests (xii) mechanical tests (xiii) outsourcing (third party) laboratory testing.
Clinical Testing:
(i) Role of clinical testing, (ii) creating and implementing clinical tests, (iii) clinical practices for excellence, and (iv) documentation of findings.
Product development methodologies:
(i) Initiation, (ii) planning, (iii) execution, monitoring, and control (iv) verification and validation (v) review meetings and evaluation of product development progress.
Module Content & Assessment
Assessment Breakdown%
Continuous Assessment60.00%
Project40.00%

Assessments

Full Time

Continuous Assessment
Assessment Type Examination % of Total Mark 30
Timing Week 7 Learning Outcomes 1,2,3
Non-marked No
Assessment Description
Class Assessment
Assessment Type Examination % of Total Mark 30
Timing Week 14 Learning Outcomes 4,5
Non-marked No
Assessment Description
Class Assessment
Project
Assessment Type Project % of Total Mark 40
Timing n/a Learning Outcomes 2,3
Non-marked No
Assessment Description
Assignment Exercise
No Practical
No End of Module Formal Examination
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.

SETU Carlow Campus reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Category Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Delivery will consist of lectures/tutorial sessions. Every Week 3.00 3
Independent Learning Non Contact Reading, assignments, study, tutorials, applied laboratory experiments and exercises. Every Week 3.00 3
Total Weekly Contact Hours 3.00
 
Module Resources
Recommended Book Resources
  • Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo,. (2015), Medical Devices: Regulations, Standards and Practices, Woodhead Publishing, [ISBN: 978-008100289].
This module does not have any article/paper resources
This module does not have any other resources
Discussion Note: