Computerised Systems & Data Quality for Medtech - Galway
The aim of this special purpose award is to provide students with the skills required to add value in an ever-evolving manufacturing environment (with a focus on medical device manufacture).
| Award Name | Special Purpose Certificate (Level 8 NFQ) |
|---|---|
| NFQ Classification | Special Purpose |
| Awarding Body | Atlantic Technological University |
| NFQ Level | Level 8 NFQ |
| Award Name | NFQ Classification | Awarding Body | NFQ Level |
|---|---|---|---|
| Special Purpose Certificate (Level 8 NFQ) | Special Purpose | Atlantic Technological University | Level 8 NFQ |
Duration
1 year part-time, blended.
Recommended Study Hours per week
6.5 hours per week class time.
On-Campus Attendance Requirement
Mandatory attendance at workshops – usually once (maximum twice) per semester.
Note: Check programme Examination and Assessment requirements, as they may involve examinations to be taken on campus.
Further information
Start Date September 2025
Total Fees €1,250
Flexible learning courses are popular, and they fill on a first come, first served basis. There are two major intake periods throughout the academic year, September and January.
For January start courses, applications typically open in October, and for September start courses, applications typically open in February. Closing dates for applications are listed on the individual course webpage.
The aim of this special purpose award is to provide students with the skills required to add value in an ever-evolving manufacturing environment (with a focus on medical device manufacture).
All aspects of medical device manufacturing and quality management are becoming more and more dependent on automation. Software and automation are present everywhere in todays manufacturing environment, from increasingly sophisticated equipment, to automated business process flows in ERP (Enterprise Resource Planning) systems, and the management of a myriad of data from analytical test outputs to quality trend analysis and other management data.
This course will cover the key area of validation of software and automated systems.There will be a significant emphasis on actual industry examples and opportunities for participants to practice what they learn in workshop-style classes and assignments. Validation documents will be created by the students and critiqued as they would be in industry, leaving the learner in a much more confident position to take up a validation role.
Learners will also cover data and the importance of data integrity in a regulated environment. There is a well-documented increase in the regulatory focus on data and the management thereof. There will be a focus on the integrity of data.
As there is much growth, development and innovation in this area, it is timely to include a module on Emerging Software Trends, which will cover topics, from the evolving definition of a medical device to include software; to innovations in machine learning and artificial intelligence.
We have a highly experienced lecturing team and strong industry partnerships to support this module and the added benefits of guest lectures and real industry examples.
Who Should Apply?
Anyone looking to move into or evolve within a CSV / software quality role. Previous students include Quality engineers, production managers, validation engineers and automation business owners.
Semester Module Details Credits Mandatory / Elective
1 Data Use and Integrity 05 Mandatory
2 Managing Validation Projects 05 Mandatory
Year Software and Automated System Validation 10 Mandatory
Year Emerging Medtech Software Trends 05 Mandatory
Examination and Assessment
Two modules are 100% continuous assessment. Two are 50% continuous assessment and 50% final exam.
Note: Where assessment on the programme involves examinations, these are held on campus or at another exam venue in the Republic of Ireland. There are typically two exam periods: January and May. Times scheduled for examinations (face to face / online exams ) are in GMT.
Department of Analytical, Biopharmaceutical and Medical Sciences
Dr Eugene Mc Carthy
Head of Department
For application queries contact:
E: learn.galwaymayo@atu.ie