Module Details
Module Code: |
LAWS C3603 |
Module Title:
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Medical Device Standards and Regulations
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Title:
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Medical Device Standards and Regulations
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Module Level:: |
7 |
Module Coordinator: |
Cathal Nolan
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Module Author:: |
Darren Kavanagh
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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.
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Learning Outcomes |
On successful completion of this module the learner will be able to: |
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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.
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No recommendations listed |
Co-requisite Modules
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No Co-requisite modules listed |
Additional Requisite Information
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No Co Requisites listed
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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).
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Quality Management Systems:
(i) Manufacturing practice for excellence (ii) ISO 13485 (iii) comparison of ISO and cGMP, and (iv) FDA CFR820.
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Approval Process for New Medical Devices:
(i) European Union (ii) the United States (iii) China, and (iv) other jurisdictions.
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Risk Assessment Management:
(i) Risk analysis and techniques (ii) risk acceptability, and (iii) risk management reporting.
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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.
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Clinical Testing:
(i) Role of clinical testing, (ii) creating and implementing clinical tests, (iii) clinical practices for excellence, and (iv) documentation of findings.
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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.
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Module Content & Assessment
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Assessment Breakdown | % |
Continuous Assessment | 60.00% |
Project | 40.00% |
AssessmentsFull Time
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.
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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 |
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Contact |
Delivery will consist of lectures/tutorial sessions. |
Every Week |
3.00 |
3 |
Independent Learning |
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Non Contact |
Reading, assignments, study, tutorials, applied laboratory experiments and exercises. |
Every Week |
3.00 |
3 |
Total Weekly Contact Hours |
3.00 |
Module Resources
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Recommended Book Resources |
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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 |
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This module does not have any other resources |
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