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Premarketing Regulation - Clinical Trials
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EXPERT VIEW
Assessing the size of the US recall issue
27 April 2011
Ashley Yeo
With the US in mid-regulatory review, stakeholders are keenly pushing for a safer and faster system, but there are different views on how these goals should be achieved. That was shown at a hearing of the US Senate's Special Committee on Aging 1 . ...
LATEST FEATURES
The revision of the EU medical device directives revision and variations in national laws
12 January 2011
How successful have the EU member states been in implementing the revision of the medical device directives into national law? And has this been done ...
test-Understanding the US Programme for Bioresearch Monitoring
16 November 2010
Following the pledge by the Food and Drug Administration to step up efforts regarding its programme for ensuring the validity of the scientific data ...
Is it Time for a Single Set of Device-Related GCPs in the EU?
21 September 2009
Marja de Jong and Herman Pieterse argue that the time has come to consolidate biomedical ethical requirements for European Union medical device ...
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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 Española del Medicamento, the ...
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MULTIMEDIA
RAJ Devices News Roundup, 11 December 2009
28 July 2011
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EVENTS
Overview of ISO 13485:2003, the CMDRs, the MDD, and JPAL
21September 2009
Minneapolis (MN), US
