Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
Book of modulesMTQ2 - MTQ2 Certificate in Medical Technologies RegulatoryAffairs and Quality
6 modules listed.
13:41PM Thursday, 24 August 2017
Generated with Akari Document
Course Stream MTQ2 - MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality · 24 August 2017
APPROVED
MTQ2 Certificate in Medical Technologies Regulatory Affairs and QualityAwards
No Programme Award Assigned
Course Stream Code: MTQ2
Mode of Delivery: Part Time
No. of Semesters : 2
NFQ Level: 8
EQF Level: 6
EHEA Level: First Cycle
Embedded Award: No
Course Stream Short Title: Certificate in MedTech Regulatory Affairs and Quality
Language of Instruction: English
Valid From: 2017-18 (01-09-17 – 31-08-18)
Course: Certificate in Medical Technologies Regulatory Affairs and Quality
Discipline: College of Science
Location: NUIG
Course Stream Director: TERRY SMITH
Educational Aim of Course Stream: n/a
Clearing House Code: GYS281.
Course Stream MTQ2 - MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality · 24 August 2017
Semester Schedules
Code: 1MTQ2 / Location: NUIG / 30 ECTS / Semester 1
Optional
Mod Code Module Title Co-ordinator Level ECTSCredits
FT ContactHours
PT ContactHours
WrittenAssessment
ContinuousAssessment
Oral, AudioVisual orPracticalAssessment
Department-basedAssessment
Research Study Abroad Computer-basedAssessment
MTR1101 Introduction toQualityManagementSystems(Approved)
8 5 0.00 1.42 0 100 0 0 0 0 0
MTR1102 Fundamentalsof EU MedicalDeviceRegulations(Approved)
8 5 0.00 1.42 0 100 0 0 0 0 0
MTR1103 Auditing andCompliance(Approved)
8 5 0.00 1.42 0 100 0 0 0 0 0
Course Stream MTQ2 - MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality · 24 August 2017
Code: 1MTQ2 / Location: NUIG / 30 ECTS / Semester 2
Optional
Mod Code Module Title Co-ordinator Level ECTSCredits
FT ContactHours
PT ContactHours
WrittenAssessment
ContinuousAssessment
Oral, AudioVisual orPracticalAssessment
Department-basedAssessment
Research Study Abroad Computer-basedAssessment
MTR1104 Fundamentalsof US MedicalDeviceRegulations(Approved)
8 5 0.00 1.42 0 100 0 0 0 0 0
MTR1105 RiskAssessment(Approved)
8 5 0.00 1.42 0 100 0 0 0 0 0
MTR1106 Validation andCalibration(Approved)
8 5 0.00 1.42 0 100 0 0 0 0 0
Year 1 Awards :
Certificate in Science in Medical Technology Regulatory Affairs and Quality
Course Stream MTQ2 - MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality · 24 August 2017
PO DeliveryNo Course Stream Outcomes Data has been attached to this Course Stream yet.
Course Stream MTQ2 - MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality · 24 August 2017
Who Can AccessStaff Member Staff Number
CORA COSTELLO 0023560S
CLAIRE MITCHELL 0023293S
TERRY SMITH 0060798S
Sheila Coyle 0023186S
Emer Toner 0001761S
SANDRA GANLY 0105689S
OLIVIA MC DERMOTT 0111815S
MTR1101: Introduction toQuality ManagementSystems( Semester:1 Optional )
Module Details
Title Short: Introduction to Quality Management Systems APPROVED
Language of Instruction: English
Module Code: MTR1101
ECTS Credits: 5
NFQ Level: 8
EQF Level: 6
EHEA Level: First Cycle
Valid From: 2017-18 (01-09-17 – 31-08-18)
Teaching Period: Semester 1
Module Delivered in 1 programme(s)
Module Owner: TERRY SMITH
Module Discipline: NAT_SCI - School of Natural Sciences
Module Data: 1.7 - 2 LAB
Module Description: This module aims to provide students with an introduction to and understanding of setting up a basic QMSand its implementation. It also aims to provide the students with an understanding of the requirement for aquality management system and how to design this quality system under the CFR 820 or ISO13485headings.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Describe the evolution of Quality Management Systems
LO2 Describe a basic QMS and its components
LO3 Explain the application and requirements of a QMS as prescribed by 21CFR 820
LO4 Explain the application and requirements of a QMS as prescribed by ISO13485:2016
LO5 Describe the quality tools necessary to implement and achieve continuous quality improvement in the manufacturing
LO6 Illustrate the audit requirements of a QMS and how to deal with auditors
MTR1101: Introduction toQuality ManagementSystems( Semester:1 Optional )
Module Content & Assessment
Indicative Content
No indicative content
No Written Assessment
Continuous Assessment
AssessmentType
AssessmentDescription
Outcomeaddressed
% oftotal
MarksOut of
PassMarks
Sitting AssessmentPeriod
AssessmentDate
Duration Mandatory
ContinuousAssessment1
Assignments,case studiesand writtenreviews
1,2,3,4,5,6 100.00 100 40 FirstSitting
Semester 1 n/a 0 True
ContinuousAssessment1
Assignments,case studiesand writtenreviews
1,2,3,4,5,6 100.00 100 40 SecondSitting
Autumn n/a 0 True
No Oral, Audio Visual or Practical Assessment
No Department-based Assessment
No Research
No Study Abroad
No Computer-based Assessment
The institute reserves the right to alter the nature and timings of assessment
MTR1101: Introduction toQuality ManagementSystems( Semester:1 Optional )
MTR1101: Introduction toQuality ManagementSystems( Semester:1 Optional )
Module Workload
This module has no Full Time workload.
Workload: Part Time
Workload Type WorkLoad Description LearningOutcomes
Hours Frequency AverageWeeklyLearnerWorkload
Lecture Online lectures and tutorials 12 PerSemester
1.00
Independent & DirectedLearning (Non-contact)
Directed and self-directed learning 100 PerSemester
8.33
Lab Practical workshops 5 PerSemester
0.42
Total Hours 117.00
Total Weekly Learner Workload 9.75
Total Weekly Contact Hours 1.42
Module Resources
Recommended Book Resources
David L. Goetsch, University of West Florida and Oskaloosa-Walton 2016, Quality Management for Organizational Excellence, 8thEd., Pearson [ISBN: 9780133791853]
This module does not have any article/paper resources
Other Resources
Website: FDAWewbsite, FDAhttps://www.accessdata.fda.gov/scripts/c drh/cfdocs/cfCFR/CFRSearch.cfm
Website: ISO.orgwebsite, ISOhttps://www.iso.org/standard/36786.html
Module Full Time Equivalent
Module Full Time Equivalent
Discipline %
School of Natural Sciences 100
Module Delivered in
Course Stream Code Course Stream Title
MTQ2 MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality (Approved)
MTR1102: Fundamentals ofEU Medical DeviceRegulations( Semester:1 Optional )
Module Details
Title Short: Fundamentals of EU Medical Device Regulations APPROVED
Language of Instruction: English
Module Code: MTR1102
ECTS Credits: 5
NFQ Level: 8
EQF Level: 6
EHEA Level: First Cycle
Valid From: 2017-18 (01-09-17 – 31-08-18)
Teaching Period: Semester 1
Module Delivered in 1 programme(s)
Module Owner: TERRY SMITH
Module Discipline: NAT_SCI - School of Natural Sciences
Module Description: This module aims to provide students with an introduction to and a fundamental understanding of currentand upcoming EU legislation as it applies to medical devices and to provide students with an understandingof the EU classification system and potential regulatory pathways for placing medical devices on the marketin the EU. It also aims to provide the students with an understanding of the utilisation of standards andguidance documents (MEDDEVs, NBOGs and NBMEDS).
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Describe the evolution of current legislation and reasons for upcoming revised legislation
LO2 Classify a medical device under EU requirements
LO3 Analyse and navigate key guidance documents
LO4 Define an appropriate regulatory pathway for a number of device classifications and associated conformity assessmentroutes
LO5 Make change control assessments for common change types
LO6 Identify the key documents required in technical documentation to support an EU regulatory submission
LO7 Analyse the role and expectations of the manufacturer, authorized representative, notified body and Competent Authority
LO8 Describe the basics of ISO 13485:2016, PMS Requirements and Vigilance Requirements
MTR1102: Fundamentals ofEU Medical DeviceRegulations( Semester:1 Optional )
Module Content & Assessment
Indicative Content
No indicative content
No Written Assessment
Continuous Assessment
AssessmentType
AssessmentDescription
Outcomeaddressed
% oftotal
MarksOut of
PassMarks
Sitting AssessmentPeriod
AssessmentDate
Duration Mandatory
ContinuousAssessment1
Assignments 1,2,3,4,5,6,7,8 100.00 100 40 FirstSitting
Semester 1 n/a 0 True
ContinuousAssessment1
Assignments 1,2,3,4,5,6,7,8 100.00 100 40 SecondSitting
Autumn n/a 0 True
No Oral, Audio Visual or Practical Assessment
No Department-based Assessment
No Research
No Study Abroad
No Computer-based Assessment
The institute reserves the right to alter the nature and timings of assessment
MTR1102: Fundamentals ofEU Medical DeviceRegulations( Semester:1 Optional )
MTR1102: Fundamentals ofEU Medical DeviceRegulations( Semester:1 Optional )
Module Workload
This module has no Full Time workload.
Workload: Part Time
Workload Type WorkLoad Description LearningOutcomes
Hours Frequency AverageWeeklyLearnerWorkload
Lecture Online lectures and tutorials 12 PerSemester
1.00
Independent Learning Directed and self-directed learning 100 PerSemester
8.33
Lab Practical workshops 5 PerSemester
0.42
Total Hours 117.00
Total Weekly Learner Workload 9.75
Total Weekly Contact Hours 1.42
Module Resources
This module does not have any book resources
This module does not have any article/paper resources
Other Resources
Website: Irish Competent Authority (HPRA)website, Health Product Regulatory Authorityhttps://www.hpra.ie/homepage/medical-dev ices/regulatory-information
Website: European Medicines Agency (EMA)websitehttp://ec.europa.eu/growth/sectors/medic al-devices/index_en.htm
Module Full Time Equivalent
Module Full Time Equivalent
Discipline %
School of Natural Sciences 100
Module Delivered in
Course Stream Code Course Stream Title
MTQ2 MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality (Approved)
Module Instructors
Module Instructors
Staff Member Staff Email
No Teacher Staff Assigned
MTR1103: Auditing andCompliance( Semester:1 Optional )
Module Details
Title Short: Auditing and Compliance APPROVED
Language of Instruction: English
Module Code: MTR1103
ECTS Credits: 5
NFQ Level: 8
EQF Level: 6
EHEA Level: First Cycle
Valid From: 2017-18 (01-09-17 – 31-08-18)
Teaching Period: Semester 1
Module Delivered in 1 programme(s)
Module Owner: TERRY SMITH
Module Discipline: NAT_SCI - School of Natural Sciences
Module Description: This module introduces the regulatory requirement for GMP & compliance auditing, its benefits to anorganisation and the tools required by an effective auditor. In addition, it also introduces corrective andpreventive action, non conformance reporting and ongoing compliance.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Interpret and explain the relevance of auditing as a means of monitoring the production of safe and effective medtechproducts in a GMP environment
LO2 Describe the various auditing techniques available and the regulatory basis for GMP/compliance auditing
LO3 Source, interpret and apply GMP principles to different case scenarios
LO4 Roleplay and participate in a multidisciplinary team of auditors within a GMP environment
LO5 Critique the performance of a systematic and independent examination of the effectiveness of a quality system
LO6 Identify, assess and analyse breaches of GMP and recommend appropriate corrective and preventive actions
LO7 Evaluate non-conformance statements and understand the non conformance management process
MTR1103: Auditing andCompliance( Semester:1 Optional )
Module Content & Assessment
Indicative Content
No indicative content
No Written Assessment
Continuous Assessment
AssessmentType
AssessmentDescription
Outcomeaddressed
% oftotal
MarksOut of
PassMarks
Sitting AssessmentPeriod
AssessmentDate
Duration Mandatory
ContinuousAssessment1
Assignments 1,2,3,4,5,6,7 100.00 100 40 FirstSitting
Semester 1 n/a 0 True
ContinuousAssessment1
Assignments 1,2,3,4,5,6,7 100.00 100 40 SecondSitting
Autumn n/a 0 True
No Oral, Audio Visual or Practical Assessment
No Department-based Assessment
No Research
No Study Abroad
No Computer-based Assessment
The institute reserves the right to alter the nature and timings of assessment
MTR1103: Auditing andCompliance( Semester:1 Optional )
MTR1103: Auditing andCompliance( Semester:1 Optional )
Module Workload
This module has no Full Time workload.
Workload: Part Time
Workload Type WorkLoad Description LearningOutcomes
Hours Frequency AverageWeeklyLearnerWorkload
Lecture Online lectures and tutorials 12 PerSemester
1.00
Independent & DirectedLearning (Non-contact)
Directed and self-directed learning 100 PerSemester
8.33
Lab Practical workshops 5 PerSemester
0.42
Total Hours 117.00
Total Weekly Learner Workload 9.75
Total Weekly Contact Hours 1.42
Module Resources
Recommended Book Resources
Carl T. DeMarco., Medical device design and regulation, Milwaukee, Wis; ASQ Quality Press [ISBN: 9780873898164]
Dennis.R.Arter 2002, Quality audits for improved performance, 3rd Ed., ASQ [ISBN: 978-0-87389-5]
This module does not have any article/paper resources
This module does not have any other resources
Module Full Time Equivalent
Module Full Time Equivalent
Discipline %
Inter-Institutional 100
Module Delivered in
Course Stream Code Course Stream Title
MTQ2 MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality (Approved)
Module Instructors
Module Instructors
Staff Member Staff Email
No Teacher Staff Assigned
MTR1104: Fundamentals ofUS Medical DeviceRegulations( Semester:2 Optional )
Module Details
Title Short: Fundamentals of US Medical Device Regulations APPROVED
Language of Instruction: English
Module Code: MTR1104
ECTS Credits: 5
NFQ Level: 8
EQF Level: 6
EHEA Level: First Cycle
Valid From: 2017-18 (01-09-17 – 31-08-18)
Teaching Period: Semester 2
Module Delivered in 1 programme(s)
Module Owner: TERRY SMITH
Module Discipline: NAT_SCI - School of Natural Sciences
Module Description: This module aims to provide students with an introduction to and a fundamental understanding of currentUS legislation as it applies to medical devices and to provide students with an understanding of the US FDAclassification system and potential regulatory pathways for placing medical devices on the market in the US.It also aims to provide the students with an understanding of the utilisation of standards and FDA guidancedocuments.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Describe the evolution of current legislation
LO2 Classify a medical device under US requirements
LO3 Analyse and navigate key guidance documents and consensus standards and key FDA medical device databases
LO4 Define an appropriate regulatory pathway for a number of device classifications
LO5 Make change control assessments for common change types
LO6 Identify the key documents required in technical documentation to support a US regulatory submission
LO7 Evaluate how to interact effectively with FDA agents/reviewers
LO8 Evaluate the basics of US QSRs, PMS Requirements and Vigilance Requirements and navigate the US FDA MAUDEdatabase
MTR1104: Fundamentals ofUS Medical DeviceRegulations( Semester:2 Optional )
Module Content & Assessment
Indicative Content
No indicative content
No Written Assessment
Continuous Assessment
AssessmentType
AssessmentDescription
Outcomeaddressed
% oftotal
MarksOut of
PassMarks
Sitting AssessmentPeriod
AssessmentDate
Duration Mandatory
ContinuousAssessment1
Assignments 1,2,3,4,5,6,7,8 100.00 100 40 FirstSitting
Semester 2 n/a 0 True
ContinuousAssessment1
Assignments 1,2,3,4,5,6,7,8 100.00 100 40 SecondSitting
Autumn n/a 0 True
No Oral, Audio Visual or Practical Assessment
No Department-based Assessment
No Research
No Study Abroad
No Computer-based Assessment
The institute reserves the right to alter the nature and timings of assessment
MTR1104: Fundamentals ofUS Medical DeviceRegulations( Semester:2 Optional )
MTR1104: Fundamentals ofUS Medical DeviceRegulations( Semester:2 Optional )
Module Workload
This module has no Full Time workload.
Workload: Part Time
Workload Type WorkLoad Description LearningOutcomes
Hours Frequency AverageWeeklyLearnerWorkload
Lecture Online lectures and tutorials 12 PerSemester
1.00
Independent & DirectedLearning (Non-contact)
Directed and self-directed learning 100 PerSemester
8.33
Lab Practical workshops 5 PerSemester
0.42
Total Hours 117.00
Total Weekly Learner Workload 9.75
Total Weekly Contact Hours 1.42
Module Resources
Recommended Book Resources
Mantus, Pisano 2014, FDA Regulatory Affairs, 3rd Ed., CRC Press [ISBN: 9781841849201]
Carl T. DeMarco., Medical device design and regulation, Milwaukee, Wis; ASQ Quality Press [ISBN: 9780873898164]
This module does not have any article/paper resources
This module does not have any other resources
Module Full Time Equivalent
Module Full Time Equivalent
Discipline %
School of Natural Sciences 100
Module Delivered in
Course Stream Code Course Stream Title
MTQ2 MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality (Approved)
Module Instructors
Module Instructors
Staff Member Staff Email
No Teacher Staff Assigned
MTR1105: Risk Assessment( Semester:2 Optional )
Module Details
Title Short: Risk Assessment APPROVED
Language of Instruction: English
Module Code: MTR1105
ECTS Credits: 5
NFQ Level: 8
EQF Level: 6
EHEA Level: First Cycle
Valid From: 2017-18 (01-09-17 – 31-08-18)
Teaching Period: Semester 2
Module Delivered in 1 programme(s)
Module Owner: TERRY SMITH
Module Discipline: NAT_SCI - School of Natural Sciences
Module Description: Understand the role of Risk assessment through the design process and product lifecycle. Understand theconcept of Risk Management and describe a basic Risk management system and its components as well asthe application and requirements of Design & Risk Management under 21CFR 820
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Analyse the concept of Risk Management
LO2 Describe a basic Risk management system and its components
LO3 Explain the application and requirements of Design & Risk Management under 21CFR 820
LO4 Explain the application and requirements of Design & Risk Management under ISO14971
LO5 Describe the risk management tools used to help manage risk in the product lifecycle
MTR1105: Risk Assessment( Semester:2 Optional )
Module Content & Assessment
Indicative Content
No indicative content
No Written Assessment
Continuous Assessment
AssessmentType
AssessmentDescription
Outcomeaddressed
% oftotal
MarksOut of
PassMarks
Sitting AssessmentPeriod
AssessmentDate
Duration Mandatory
ContinuousAssessment1
Assignments,case studiesand reviews
1,2,3,4,5 100.00 100 40 FirstSitting
Semester 2 n/a 0 True
ContinuousAssessment1
Assignments,case studiesand reviews
1,2,3,4,5 100.00 100 40 SecondSitting
Autumn n/a 0 True
No Oral, Audio Visual or Practical Assessment
No Department-based Assessment
No Research
No Study Abroad
No Computer-based Assessment
The institute reserves the right to alter the nature and timings of assessment
MTR1105: Risk Assessment( Semester:2 Optional )
MTR1105: Risk Assessment( Semester:2 Optional )
Module Workload
This module has no Full Time workload.
Workload: Part Time
Workload Type WorkLoad Description LearningOutcomes
Hours Frequency AverageWeeklyLearnerWorkload
Lecture Online lectures and tutorials 1,2,3,4,5 12 PerSemester
1.00
Independent & DirectedLearning (Non-contact)
Directed and self-directed learning 100 PerSemester
8.33
Lab Practical workshops 5 PerSemester
0.42
Total Hours 117.00
Total Weekly Learner Workload 9.75
Total Weekly Contact Hours 1.42
Module Resources
Recommended Book Resources
Ron Rael 2013, Strategy and Risk Management : An Integrated Practical Approach, 2nd Ed., John Wiley & Sons Inc. NC UnitedStates [ISBN: 9781940235219]
This module does not have any article/paper resources
Other Resources
Website: FDAwebsite, FDAhttps://www.accessdata.fda.gov/scripts/c drh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30
Website: ISOISO14971https://www.iso.org/standard/38193.html
Module Full Time Equivalent
Module Full Time Equivalent
Discipline %
School of Natural Sciences 100
Module Delivered in
Course Stream Code Course Stream Title
MTQ2 MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality (Approved)
MTR1106: Validation andCalibration( Semester:2 Optional )
Module Details
Title Short: Validation and Calibration APPROVED
Language of Instruction: English
Module Code: MTR1106
ECTS Credits: 5
NFQ Level: 8
EQF Level: 6
EHEA Level: First Cycle
Valid From: 2017-18 (01-09-17 – 31-08-18)
Teaching Period: Semester 2
Module Delivered in 1 programme(s)
Module Owner: TERRY SMITH
Module Discipline: NAT_SCI - School of Natural Sciences
Module Description: This module introduces the regulatory requirement for calibration and validation within a GMP environment,their benefits to an organisation and the tools required for effective implementation This module will preparestudents to undertake different validation roles and will equip the student to complete many validationactivities within their organisation. The impetus for the development of this module has emerged fromindustry needs and the course content has been designed to meet this industry need. This module coversthe core aspects of interpreting and/or setting quality characteristics and their verification throughappropriate calibrated Inspection, Measurement and Testing processes. The module traces the metrologicalrequirements from quality characteristics through instrument selection, evaluation and on-going calibrationso that the student is fully aware of the purpose and operation of a good measurement managementsystem.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Interpret and explain the relevance of calibration within a GMP and Quality Assurance environment.
LO2 Describe the various metrological requirements from quality characteristics through instrument selection, evaluation andongoing calibration
LO3 Outline the properties of a good measurement management system and how it links to validation
LO4 Interpret the key elements in a systematic approach to validation with an emphasis on medical device manufacture
LO5 Critique risk analysis and evaluation and how it relates validation 6. Source and interpret the industry standard guidelines inuse for validation within a GMP environment.
LO6 Source and interpret the industry standard guidelines in use for validation within a GMP environment.
LO7 Outline elements of validation documentation and understand the regulatory requirements and the use of risk managementtools in making regulatory decisions.
MTR1106: Validation andCalibration( Semester:2 Optional )
Module Content & Assessment
Indicative Content
No indicative content
No Written Assessment
Continuous Assessment
AssessmentType
AssessmentDescription
Outcomeaddressed
% oftotal
MarksOut of
PassMarks
Sitting AssessmentPeriod
AssessmentDate
Duration Mandatory
ContinuousAssessment1
Assignments 1,2,3,4,5,6 100.00 100 40 FirstSitting
Semester 2 n/a 0 True
ContinuousAssessment1
Assignments 1,2,3,4,5,6,7 100.00 100 40 SecondSitting
Autumn n/a 0 True
No Oral, Audio Visual or Practical Assessment
No Department-based Assessment
No Research
No Study Abroad
No Computer-based Assessment
The institute reserves the right to alter the nature and timings of assessment
MTR1106: Validation andCalibration( Semester:2 Optional )
MTR1106: Validation andCalibration( Semester:2 Optional )
Module Workload
This module has no Full Time workload.
Workload: Part Time
Workload Type WorkLoad Description LearningOutcomes
Hours Frequency AverageWeeklyLearnerWorkload
Lecture Online lectures and tutorials 12 PerSemester
1.00
Independent & DirectedLearning (Non-contact)
Directed and self-directed learning 100 PerSemester
8.33
Lab Practical workshops 5 PerSemester
0.42
Total Hours 117.00
Total Weekly Learner Workload 9.75
Total Weekly Contact Hours 1.42
Module Resources
This module does not have any book resources
This module does not have any article/paper resources
This module does not have any other resources
Module Full Time Equivalent
Module Full Time Equivalent
Discipline %
Inter-Institutional 100
Module Delivered in
Course Stream Code Course Stream Title
MTQ2 MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality (Approved)
Module Instructors
Module Instructors
Staff Member Staff Email
No Teacher Staff Assigned