Design and implementation of CE medical decision model on research medical devices

• Main Author: Tan, Alan Xin Ji
• Other Authors: Heng Kok Hui, John Gerard
• Format: Theses and Dissertations
• Language: English
• Published: 2016
• Subjects: DRNTU::Engineering::Mechanical engineering
• Online Access: https://hdl.handle.net/10356/66929
• Institution: Nanyang Technological University

There are many medical devices being researched and developed by academic institutions which are funded by grants. Many researchers do not have the commercial background and thus not aware of the regulatory requirements needed to be undertaken when developing such devices. In order to get the device to commercialize within the time frame of the research grant, researchers have to be aware of the regulatory requirements as they progress with the development work. To raise awareness of regulatory requirements and assist the researchers, details for acquiring the CE marking are described and used to form the basis of the CE medical decision model. The CE medical decision model consists of six simple steps for researchers to follow during the regulatory process and is applied on three different research devices. Using the decision model, it helps researchers to gain a better knowledge of fulfilling the regulatory requirements before commercializing the device.