Course Details
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Brief Description
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Module Description |
Module Code |
NFQ Level |
ECTS |
Start Date |
|
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Medical Software quality assurance |
Module 1:CS4261 Module 2:CS4271 |
8 8 |
6 9 |
Sep 2023 |
The Connected Health Skillnet, the Irish Medtech Association, and the University of Limerick (UL), are delighted to present the Medical Software Quality Assurance programme.
The programme will provide participants with fundamental theoretical and practical skills, abilities, and knowledge for assuring the quality of medical software applications in accordance with relevant state of the art regulatory requirements and quality management systems. This includes standalone software, which is a medical device, software which is part of a medical device, medical device apps and for software used in the Medtech regulated environment. Participants will be capable of creating and executing test cases and tracking software issues from their diagnosis to resolution and assuring the quality of developed software. This course has a proven record of successfully delivering excellent content to participants who have included Testers, Software Engineers, Project Managers, QA Personnel, Quality Managers, Technical Consultants and Senior Managers.
Learning outcomes:
- Explain the key terminology in medical software
- Understand Medical Software Quality principals, methods, and tools
- Understand the difference between Medical Device Software and Generic software
- Recognise the effects of regulations on the Quality Assurance process
- Be knowledgeable on how testing is implemented in the Medical Device industry
- Create documentation in line with a Quality Management System
- Construct a protocol and test scripts from a requirements document
- Verify that user manuals are regulatory and standards compliant
- Participate in localisation teams
- Review design documentation
- Acknowledge the professional and ethical responsibility of medical software practitioners to produce safe and reliable software
3rd Level qualification (certification, diploma, degree) in Software, Engineering, Quality, or a Science related discipline desired. Experience in software Quality Assurance activities, such as software testing, will be considered in lieu of a third level qualification
Members €2,280
Non-members €3,800
Connected Health Skillnet fund this programme,
*Skillnet membership is free for private sector companies based in ROI
This course has a proven record of successfully delivering excellent content to participants who have included Testers, Software Engineers, Project Managers, QA Personnel, Quality Managers, Technical Consultants and Senior Managers.