Design and implementation of CE medical decision model on research medical devices
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...
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| Formato: | Tese |
| Idioma: | English |
| Publicado em: |
2016
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| Acesso em linha: | https://hdl.handle.net/10356/66929 |
| _version_ | 1826124381994090496 |
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| author | Tan, Alan Xin Ji |
| author2 | Heng Kok Hui, John Gerard |
| author_facet | Heng Kok Hui, John Gerard Tan, Alan Xin Ji |
| author_sort | Tan, Alan Xin Ji |
| collection | NTU |
| description | 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. |
| first_indexed | 2024-10-01T06:19:42Z |
| format | Thesis |
| id | ntu-10356/66929 |
| institution | Nanyang Technological University |
| language | English |
| last_indexed | 2024-10-01T06:19:42Z |
| publishDate | 2016 |
| record_format | dspace |
| spelling | ntu-10356/669292023-03-11T17:44:13Z Design and implementation of CE medical decision model on research medical devices Tan, Alan Xin Ji Heng Kok Hui, John Gerard School of Mechanical and Aerospace Engineering DRNTU::Engineering::Mechanical engineering 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. MASTER OF ENGINEERING (MAE) 2016-05-05T08:06:03Z 2016-05-05T08:06:03Z 2016 Thesis Tan, A. X. J. (2016). Design and implementation of CE medical decision model on research medical devices. Master’s thesis, Nanyang Technological University, Singapore. https://hdl.handle.net/10356/66929 10.32657/10356/66929 en 146 p. application/pdf |
| spellingShingle | DRNTU::Engineering::Mechanical engineering Tan, Alan Xin Ji Design and implementation of CE medical decision model on research medical devices |
| title | Design and implementation of CE medical decision model on research medical devices |
| title_full | Design and implementation of CE medical decision model on research medical devices |
| title_fullStr | Design and implementation of CE medical decision model on research medical devices |
| title_full_unstemmed | Design and implementation of CE medical decision model on research medical devices |
| title_short | Design and implementation of CE medical decision model on research medical devices |
| title_sort | design and implementation of ce medical decision model on research medical devices |
| topic | DRNTU::Engineering::Mechanical engineering |
| url | https://hdl.handle.net/10356/66929 |
| work_keys_str_mv | AT tanalanxinji designandimplementationofcemedicaldecisionmodelonresearchmedicaldevices |