Effects of medical device legislation on innovation within Australian manufacturing companies

Autor:	Alexander Svistounov, Kristin Munday, Colin Kestell, Karen Adams
Rok vydání:	2007
Předmět:	Engineering Medical device business.industry Project commissioning media_common.quotation_subject Legislation Product (business) Quality management system Publishing Management of Technology and Innovation New product development Quality (business) Marketing business media_common
Zdroj:	Innovation. 9:343-350
ISSN:	2204-0226 1447-9338
DOI:	10.5172/impp.2007.9.3-4.343
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::ba5477cc31192a04829a374fcf23b8f5 https://doi.org/10.5172/impp.2007.9.3-4.343 Zobrazit plný text záznamu Plný text ve formátu PDF