Module Details

Module Code: COMP C9045
Full Title: Software Design and Validation for Healthcare Software
Valid From:: Semester 1 - 2024/25 ( September 2024 )
Language of Instruction:English
Duration: 1 Semester
Credits:: 7.5
Module Owner::
  • Fergal McCaffery
  • Martin Mchugh
Departments: Visual and Human-Centred Computing
Module Description: This module aims to provide students with a conceptual knowledge of the principles and techniques for medical device software design and validation that will satisfy regulatory bodies.
 
Module Learning Outcome
On successful completion of this module the learner will be able to:
# Module Learning Outcome Description
MLO1 Propose the steps involved in taking a healthcare software product from concept right through to delivery when presented with a healthcare software product that is to be marketed within a particular region. This will be achieved by justifying the safety classification of the medical device software and implementing the appropriate software development risk management practices in line with the relevant regulatory standards
MLO2 Develop a best-practice process for a particular phase of the software development lifecycle
MLO3 Evaluate the suitability of adopting a particular lifecycle model to develop and maintain a healthcare software product
MLO4 Evaluate Software Prototyping Methodologies
MLO5 Develop healthcare software in the cloud
Pre-requisite learning
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named DkIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
No recommendations listed
 
Module Indicative Content
Evolution of Medical Device Software
Why should medical device software be validated? Regulations within the different global regions - including the FDA and EU regulations and the associated standards. Classification of medical device software within different regions. Categories of medical device software. Standards required for regulatory compliance within different regions.
Medical Device Software Development
Medical Device Software Processes. Medical Device Software Development Lifecycles and Approaches IEC 62304 Standard. Different Phases of Development & Maintenance. Medical Device Software Verification and Validation. Medical Device Software Risk Management. Test First Development in the software development process. Agile Product Development Documentation for Risk Medical Device Security
Supporting Activities
Quality Management Systems. Planning. Configuration Management. Defect Management. Reviews. Traceability. Supplier Selection Handling 3rd Party Software. Medical Device CyberSecurity. Risk Management of Medical IT Networks.
Innovation
MVP Development Design Thinking No code/low code Cloud Development Technologies Artificial Intelligence for Medical Device Software
Module Assessment
Assessment Breakdown%
Course Work100.00%
Module Special Regulation
 

Assessments

Full-time

Course Work
Assessment Type Written Report % of Total Mark 60
Marks Out Of 0 Pass Mark 0
Timing S1 Week 8 Learning Outcome 1,2,3,4
Duration in minutes 0
Assessment Description
Classification of Medical device software CA
Assessment Type Written Report % of Total Mark 40
Marks Out Of 0 Pass Mark 0
Timing S1 Week 13 Learning Outcome 2,3,4,5
Duration in minutes 0
Assessment Description
Written report on the challenges to Digital Healthcare in relation to Security and AI – and how technology can also be used to advance this domain
No Project
No Practical
No Final Examination

Part-time

Course Work
Assessment Type Written Report % of Total Mark 60
Marks Out Of 0 Pass Mark 0
Timing S1 Week 8 Learning Outcome 1,2,3,4
Duration in minutes 0
Assessment Description
Classification of Medical device software CA
Assessment Type Written Report % of Total Mark 40
Marks Out Of 0 Pass Mark 0
Timing S1 Week 13 Learning Outcome 2,3,4,5
Duration in minutes 0
Assessment Description
Written report on the challenges to Digital Healthcare in relation to Security and AI – and how technology can also be used to advance this domain
No Project
No Practical
No Final Examination
Reassessment Requirement
A 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.

DKIT reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full-time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact No Description Every Week 2.00 2
Tutorial Contact The tutorials will be used for developing medical device software lifecycle processes/ models/designs for given problem scenarios. Every Week 1.00 1
Directed Reading Non Contact No Description Every Week 4.00 4
Independent Study Non Contact No Description Every Week 7.00 7
Total Weekly Learner Workload 14.00
Total Weekly Contact Hours 3.00
Workload: Part-time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact No Description Every Week 2.00 2
Tutorial Contact The tutorials will be used for developing medical device software lifecycle processes/ models/designs for given problem scenarios. Every Week 1.00 1
Directed Reading Non Contact No Description Every Week 4.00 4
Independent Study Non Contact No Description Every Week 7.00 7
Total Weekly Learner Workload 14.00
Total Weekly Contact Hours 3.00
 
Module Resources
Recommended Book Resources
  • David A. Vogel. (2011), Medical Device Software: Verification, Validation and Compliance, Artech House, [ISBN: 987-1-59693-422-1].
  • John Burton, Editors: Ita Richardson, Fergal McCaffery & Micheal Ó hAodha,. (2009), The Medical Device Industry: Developments in Software Risk Management, Cambridge Scholars Publishing, [ISBN: 9781443805612].
  • Richard C. Fries. (2006), Reliable Design of Medical Devices, CRC Press – Taylor and Francis Group, [ISBN: 0-8247-2375-].
  • Richard C. Fries. (2001), Handbook of Medical Device Design, Marcel Dekker Inc, [ISBN: 0-8247-0399-5].
  • Martin Fowler. (2004), Refactoring: Improving the design of existing code, Addison Welsey, [ISBN: 0-201-48567-2].
  • Robert C. Martin. (2003), Agile Software Development, Principles, Patterns, and Practices, Pearson, [ISBN: 0135974445].
  • Noushin Ashrafi, Hessam Ashrafi. (2008), Object Oriented Systems Analysis and Design, Pearson Education; International, [ISBN: 0131354795].
Supplementary Book Resources
  • Andy Oram, Greg Wilson. (2007), Beautiful Code: Leading Programmers Explain How They Think, O'Reilly Media, [ISBN: 0596510047].
  • Philip A. Laplante. (2011), Encyclopedia of Software Engineering, Taylor & Francis Group, [ISBN: 978-1-42-0059].
This module does not have any article/paper resources
Other Resources