Course Details

Course Code(s):
CS4261
Available:
Part-Time
Course Start Date:
September 2022
Duration:
Sept 22 - Mar 23
Award:
University Certificate of Study
Qualification:
NFQ Level 8 Minor Award
Faculty: Science and Engineering
Course Type: Professional/Flexible
Fees: For Information on Fees, see section below.
Application Deadline:

Contact(s):

Name: Jennifer McCormack
Address: Connected Health Skillnet Email: jennifer.mccormack@ibec.ie
Express Interest

Register your interest here for more information or to be notified when applications are open.

Brief Description

Please ensure you enter the Module Code below when applying for this module. Applications without this cannot be processed. You may apply for more than one module under the same application.

Module Description

Module Code

NFQ Level

ECTS

Start Date

 

Medical Software quality assurance

Module 1:CS4261

Module 2:CS4271

8

8

6

9

Sep 2023

Brochure Link

 

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:  

  1. Explain the key terminology in medical software
  2. Understand Medical Software Quality principals, methods, and tools
  3. Understand the difference between Medical Device Software and Generic software
  4. Recognise the effects of regulations on the Quality Assurance process
  5. Be knowledgeable on how testing is implemented in the Medical Device industry
  6. Create documentation in line with a Quality Management System
  7. Construct a protocol and test scripts from a requirements document
  8. Verify that user manuals are regulatory and standards compliant
  9. Participate in localisation teams
  10. Review design documentation
  11. 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

Please click here for information on funding and scholarships.

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.