Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform: Report of a policy conference of the European Society of Cardiology

Autor: Fraser AG, Daubert JC, Van de Werf F, Estes NA 3rd, Smith SC Jr, Krucoff MW, Vardas PE, Komajda M, Anker S, Auricchio A, Bailey S, Bonhoeffer P, Borggrefe M, Brodin LA, Bruining N, Buser P, Butchart E, Calle Gordo J, Cleland J, Danchin N, Degertekin M, Demade I, Denjoy N, Derumeaux G, di Mario C, Dickstein K, Dudek D, Farb A, Flotats A, Gueret P, Israel C, James S, Kautzner J, Lombardi M, Marwick T, Mioulet M, O'Kelly S, Rosano G, Rosenhek R, Sabate M, Swahn E, Tavazzi L, van der Velde E, van Herwerden L, Voigt JU, Weaver D, Wilmshurst P., PERRONE FILARDI, PASQUALE

Publikováno v: European Heart Journal
European Heart Journal, Oxford University Press (OUP): Policy B, 2011, 32 (13), pp.1673-86. ⟨10.1093/eurheartj/ehr171⟩

International audience; The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving de

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e7a9e98fa7af6de13213ce036b34a83e
http://hdl.handle.net/11588/413400