Module Overview

Medical Device Manufacturing

The module aims to provide the student with a broad understanding of the manufacture of medical devices.

Module Code

MDMG H4000

ECTS Credits


*Curricular information is subject to change

Cleanroom Technology

Classifications, particle size & counting, filtration, design and layout, standards, cleanroom airflow, commissioning and qualification.

Cleaning and Sterilisation

Cleaning requirements, cleaning systems and equipment. Sterilisation types, Ethylene Oxide, Gamma sterilisation, Electron Beam, dry heat. Modes and kinetics of microbial /endotoxin inactivation.


Function of packaging, packaging types and properties, sterilisation requirements, Labelling and packaging control. packaging manufacture, materials, methods, closure, testing and regulation.

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)

Industry relevany manufacturing processes

Surface finishing, coating technology and processes, co-extrusion

Module Content & Assessment
Assessment Breakdown %
Formal Examination70
Other Assessment(s)30