The module aims to provide the student with a broad understanding of the various medical devices available for the treatment and prevention of disease. It covers their control and regulation, as well as their modes and methods of manufacture. It also aims to provide an overview of the medical device industry both globally and nationally. It will also look at the key medical devices used in the hospital and primary care settings
Introduction to Medical Device Maufacturing
Review of the Medical Devices Industry in Ireland and worldwide. Current areas of operation, opportunities for growth and development and the future direction of the industry
Medical Device Classification
Medical Device Classification and Certification. Devides used in the treatment of neurovascular, cardiovascular, othopaedic disorders and product devlopment history
Manufacturing Processes
Introduction to manufacturing processes, polymer-based Medical devices, injection molding and extrusion. Catheter coating Process. Use of metals and other materials for the manufacture of Medical devices. Combination products
Regulatory Requirements
European Regulations, European Medical Devices Vigilance system, Global medical Devices Nomenclature system, Overview of 93/42/EEC Medical Device Directive, in-vitro diagnostic directive 98/79/EC, ISO 13485US Perspective: Classification and Medwatch Regulatory Agencies: IMB, FDA, Medical and Healthcare Products Regulatory Agency (UK, Global Harmonisation Task Force(GHTF)
Surgical Instruments
Functionality of key surgical instruments used in hospital/primary care
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 50 |
| Formal Examination | 50 |