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)
Learning Outcomes
On completion of this programme the learner should be able to
- Identify key players, market dynamics, global impact, career opportunities, and skills required in the medical device industry (Lectures 1 and 2).
- Describe emerging technologies, market trends, and sustainability practices shaping the future of medical device manufacturing (Lecture 3).
- List components and functions of Quality Management Systems and regulatory compliance requirements in the medical device industry (Lecture 4).
- Define principles and methodologies of Lean, Six Sigma, and Operational Excellence (OpEx) (Lecture 5).
- State essential elements of risk management and Corrective and Preventive Actions (CAPA) systems, including handling complaints, audits, and compliance with ISO standards and regulations (Lectures 6 and 7).
- Describe key steps and methods in process validation, testing, assembly, packaging, and traceability of medical devices, including Unique Device Identification (UDI) requirements (Lectures 8, 9, and 10).
