International Medical devices regulations

Medical Device

"It is certainly right and necessary that there is a revision and update at Community level guidelines regulate medical devices. But it must be clear that the current legislation already guarantees the safety and quality of products. This is demonstrated by the fact that in a market of millions of devices we have seen in twenty years, only a few high-profile cases of unsafe products, such as pip prostheses and heart valves Brazilian proved the result of fraud, that no law can ever eradicate of everything. "

The said Stefano Rimondi, President of Assobiomedica, during his speech at the conference "Proposal for a new regulation on medical devices" ( read the news on other themes of the workshop ), organized by the Institute of Health in collaboration with the Ministry of Health. The aim of the seminar was to take stock of the new proposed regulations on medical devices, which will be voted on July 10 by the ENVI Committee, internal to the European Parliament.

"But be careful not to upset the existing directives - said Rimondi - because approval of devices via a centralized agency or even the transfer of responsibilities to the agency of the drug there will always oppose. Rules apply to medical devices and organizations in the world of the drug does not mean to increase security, but it means destroying an industry, composed mainly of SMEs, which can not support the time and cost of the rules of the drug. "

According to the President of Assobiomedica in recent years we have witnessed a great development of medical technologies and this is partly due also to the directives prepared with great intelligence by the European Commission, which have enabled us to combine the need for security with the need for streamlined procedures, effective, fully appropriate to the nature of medical devices, is constantly evolving.

"All this has been possible - concluded Rimondi - also thanks to the excellent work of the Institute of Health and the Ministry of Health who have watched carefully on the market. Well then a smart revision of Community legislation with clear rules and strict, as long as they are consistent with the peculiarities of the industry and will help the responsible development. "


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2004-05-06 14:36:24 by eyt_sf

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Hi. I'm looking for a new job, and would appreciate any help/advice you could give me on the topic.
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-Fluent in Japanese and English
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2007-12-21 20:59:31 by shakesfear

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In 1989, the Japanese government funded the Laboratory for International Fuzzy Engineering Research with an advance of some $35 million and more than 40 member firms. Japanese cars are starting to use fuzzy transmissions. In 1989, Honda awarded its prestigious Honda prize to Zadeh for his contributions to Japanese technology. U.S. companies have been extremely reluctant to jump on the fuzzy bandwagon. Exceptions are Rockwell, which markets several fuzzy devices; Otis Elevator; and General Motors, which uses fuzzy logic in the transmission of its Saturn car.
Bart Kosko, author of Fuzzy Thinking, is the movement's most controversial and combative promoter

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