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EXPERT VIEW
Uneasy feeling for US industry as detail emerges of 510(k) overhaul
06 August 2010
Phil Greenfield
"These two preliminary reports recommend steps to strengthen and improve the 510(k) process and the use of science in decision making" and provide a "blueprint for smarter medical device oversight". That is the understated way in which Jeffrey ...
LATEST COUNTRY PROFILES
Trademarks Briefing (Devices) - Luxembourg
08 October 2009
Please give details of the major acts and directives governing trademarks. Trademarks are governed in Luxembourg by the: Benelux Convention on ...
Regulation of Medical Devices Briefing - Spain
08 October 2009
1) Which authority is responsible for overseeing the regulation of medical devices and diagnostics in Spain? Agencia EspaƱola del Medicamento, the ...
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MULTIMEDIA
RAJ Devices News Roundup, August 2010
23 August 2010
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EVENTS
Medical Device Clinical Studies
September 14th, 2010
London, UK
FDA Approval Process for Medical Devices
September 27th, 2010
London, UK
FDA Requirements for Combination Products
September 29th, 2010
London, UK