Please use this identifier to cite or link to this item: https://hdl.handle.net/10356/80610
Title: Bench to Bed: Researchers’ Limited Awareness of Regulatory Requirements to Market Medical Devices
Authors: Tan, X. J. A.
Heng, J. G. K. H.
Chua, K. P.
Foo, J. Y. A.
Keywords: Medical devices
regulatory
product development
commercialisation
Issue Date: 2015
Source: Tan, X. J. A., Heng, J. G. K. H., Chua, K. P., & Foo, J. Y. A. (2015). Bench to Bed: Researchers’ Limited Awareness of Regulatory Requirements to Market Medical Devices. Proceedings of The International Conference on Computer, Electronics, and Biomedical Engineering, 49-59.
Conference: Proceedings of The International Conference on Computer, Electronics, and Biomedical Engineering (2015:Dubai:UAE)
Abstract: In the healthcare industry, medical devices have been long used for diagnostic, therapeutic or rehabilitation purposes. Presently, they can range from a low-cost portable device that is often used for personal health monitoring to high-end sophisticated equipment that can only be operated by trained professionals. Depending on the purposes, there are then different regulatory requirements when a said device is to be marketed. While medical grade device manufacturers may know these requirements, it appears that many researchers may only have a limited understanding of them. Moreover, it is becoming increasingly common that providers of public-funded research grants are expecting that researchers to commercialise their research in order to benefit the community. In view of these, researchers now need to be more aware of these various regulatory requirements as they progress with their research grant’s development. Thus, the aims of this paper are to detail the considerations in marketing a developed product in countries that are sizable and well regulated like the European Union, cover the general approval process for the different types of devices, and describe the possible confusions pertaining to the various regulatory requirements from a researcher’s perspective and possibly that of the general public.
URI: https://hdl.handle.net/10356/80610
http://hdl.handle.net/10220/40564
URL: http://sdiwc.net/conferences/iccebe2015/
ISBN: 978-1-941968-25-3
Schools: School of Mechanical and Aerospace Engineering 
Rights: © 2015 SDIWC. This paper was published in Proceedings of The International Conference on Computer, Electronics, and Biomedical Engineering and is made available as an electronic reprint (preprint) with permission of SDIWC. The published version is available at: [http://sdiwc.net/conferences/iccebe2015/]. One print or electronic copy may be made for personal use only. Systematic or multiple reproduction, distribution to multiple locations via electronic or other means, duplication of any material in this paper for a fee or for commercial purposes, or modification of the content of the paper is prohibited and is subject to penalties under law.
Fulltext Permission: open
Fulltext Availability: With Fulltext
Appears in Collections:MAE Conference Papers

Files in This Item:
File Description SizeFormat 
ICCEBE 2015 conference 104 Bench to Bed- Regulatory Requirements to Market Medical Devices.pdf615.32 kBAdobe PDFThumbnail
View/Open

Page view(s) 50

466
Updated on Jun 18, 2024

Download(s) 20

218
Updated on Jun 18, 2024

Google ScholarTM

Check

Altmetric


Plumx

Items in DR-NTU are protected by copyright, with all rights reserved, unless otherwise indicated.