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https://hdl.handle.net/2440/44914
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Type: | Journal article |
Title: | Effects of medical device legislation on innovation within Australian manufacturing companies |
Author: | Svistounov, A. Kestell, C. Adams, K. Munday, K. |
Citation: | Innovation: Management, Policy and Practice: the international journal for innovation research, commercialization, policy analysis and best practice, 2007; 9(3-4):343-350 |
Publisher: | eContent Management Pty Ltd |
Issue Date: | 2007 |
ISSN: | 1447-9338 2204-0226 |
Abstract: | Unlike many other industries in Australia, manufacturers of medical devices must meet strict regulatory requirements to be permitted to supply their products on the consumer market. With the introduction of the Therapeutic Goods Act and Medical Device Regulations, Australian manufacturers became legally obligated to follow specific principles of quality systems implementation in design, manufacturing and product delivery processes. A survey was conducted to determine manufacturers’ perceptions of the effects of the regulation on the product development practices within their companies. Results of the survey showed that the majority of respondents are anticipating or have already experienced mostly positive effects of the legislation on quality, reliability and safety of products and legal security of their companies. However, the respondents estimate that the legislation will negatively affect the cost of innovation and delivery time of new products to the market. |
DOI: | 10.5172/impp.2007.9.3-4.343 |
Description (link): | http://www.innovation-enterprise.com/archives/vol/9/issue/3-4/article/577/effects-of-medical-device-legislation-on |
Published version: | http://dx.doi.org/10.5172/impp.2007.9.3-4.343 |
Appears in Collections: | Aurora harvest Mechanical Engineering publications |
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