This programme provides participants with an overview: of essential skills for medical device manufacturing. Focusing on key areas of the medical device landscape in Ireland, an overview of ISO13485, Regulations, QMS, Risk Management, Lean Six Sigma, Operational Excellence, Sustainability in Manufacturing and future trends of the industry.
Aims and Objectives
The aim of this course is to provide learners with an understanding of Medical Device Manufacturing, covering key industry aspects, market dynamics, and career opportunities. Participants will learn about emerging technologies, market trends, and sustainable practices, as well as Quality Management Systems and regulatory compliance. The programme includes principles of Lean, Six Sigma, and Operational Excellence (OpEx) for improving efficiency and quality, and fundamentals of risk management and Corrective and Preventive Actions (CAPA) systems, including ISO standards compliance.
Course Content
Key players, market dynamics, global impact, career opportunities, and required skills in the medical device industry.
Career paths, qualifications in medical device manufacturing.
Emerging technologies, market trends, and sustainability in medical device manufacturing.
Quality Management Systems and regulatory compliance requirements.
Lean, Six Sigma, and Operational Excellence (OpEx) principles and methodologies.
Risk management and Corrective and Preventive Actions (CAPA), including complaints, audits, and ISO compliance.
ISO standards, regulatory compliance requirements.
Overview of medical device manufacturing validation
Assembly and packaging methods ensuring product integrity and compliance.
Traceability & Unique Device Identification (U DI)
Key Benefits
Focused, practical upskilling designed to support immediate employability and progression.
- Flexible 10-week format
- Fully online
- Recorded live lectures
- Great introduction to new topics
- Quickly upskill in technical areas
- Delivered by industry experts/SMEs
- Ideal as a fast refresh/upskill option
- Foundation for moving onto QQI study programmes
- No exam
- Accessible price point
Job Opportunities
Graduates of this programme come from and progress into a wide range of roles across manufacturing, healthcare, retail and technical sectors. These include positions such as Assembler, Product Builder, QC Specialist, Regulatory Affairs Manager and Senior Validation Engineer, as well as roles in healthcare, operations and customer-facing environments — demonstrating the versatility and broad applicability of the skills developed.
