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Regulatory Region - North America
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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 . ...
INTERVIEW
The US FDA’s Medical Device Postmarket Transformation Initiative
20 May 2009
Carolyn Waterworth
US manufacturers of medical devices can expect to see increased scrutiny of their postmarketing reports as the US Food and Drug Administration ’s ...
LATEST FEATURES
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 ...
Shared responsibility in medical device safety and performance
10 September 2010
As the World Health Organization prepares for its first global medical devices forum, Michael Cheng calls on the WHO to bridge the gap – the role of ...
Off-Label Promotion in the US: Protecting Your Company and Employees
13 October 2009
Retta M Riordan examines manufacturers’ settlements with the government and provides advice on how to avoid prosecution. “Pfizer to pay record $2.3 ...
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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
PEOPLE
Michael Carome joins Public Citizen's Health Research Group
Michael Carome, an internationally recognised expert on the protection of human research subjects, has been appointed deputy director of the Health ...
New MEDEC chair appointed
James Wilson has been appointed chair of the board of directors at MEDEC , the Canadian medical technology industry association. Mr Wilson, who is ...
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EVENTS
Overview of ISO 13485:2003, the CMDRs, the MDD, and JPAL
21September 2009
Minneapolis (MN), US
