1007 次世代医療機器に対するガイドラインの策定 : 円滑な開発と審査の迅速化のために(OS13-(3)オーガナイズドセッション《生体医工学及びバイオマテリアル》)

概要

論文の詳細を見る
Guidelines for innovative medical devices such as the artificial heart, the artificial materials, equipments for regenerative medicine, DNA-chips for gene analysis, surgical robots and others are discussed and proposed. Those guidelines are terribly useful for industries that would like to propose review process at PMDA (Pharmaceuticals and Medical Devices Agency) for those innovative medical devices, and suggest evaluation methods for safety and performance of the developed medical devices. Those guidelines are related ISO and/or JIS standards are used, and discussed some standard for those medical devices. Proposed guidelines are opened the public through the METI (Ministry of Economy, Trade and Industry) homepage http://www.meti.go.jp/policy/mono_info_service/service/iryou_fukushi/index.html.
一般社団法人日本機械学会の論文
2010-08-27