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Home - Editorials
EDITORIALS
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EXPERT VIEW
In praise of the CE marking, but medtech's worst fear is still alive
06 July 2010
Ashley Yeo
The European Medicines Agency review meeting in London on 30 June passed with scarcely a mention of devices and diagnostics. This was perhaps as expected, given that the meeting, held to examine the outcomes of the assessment of Ernst & Young's ...
ANALYSIS
Industry Support of CME - the Solution, not the Problem?
05 July 2010
As doctors in the US brace themselves for the 30 million new patients that the new healthcare reform law promises to channel into the system, a key mechanism for advancing their medical knowledge and performance is facing tumultuous times. Certified ...
New Demands Edge Closer for Clinical Trial Safety Reporting in the EU
14 May 2010
The implementation deadline of 21 March has gone by and new safety reporting requirements for clinical investigations are now in place throughout the European Union. As a result of the revisions made to the medical device directives by Directive ...
E-labelling for Medical Devices in the EU Needs to Become Reality
12 January 2010
There has been talk of allowing e-labelling in the European Union for years now, yet companies still have to supply their instructions for use in hard copy. The situation could – and should – change soon, says Joachim Wilke . The change that will ...
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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, July 2010
19 July 2010
PEOPLE
State Medical Technology Alliance appoints co-chairs
Heather Erickson and Joseph Panetta have been appointed co-chairs of the State Medical Technology Alliance, a national network affiliated with US medtech industry association AdvaMed and over two dozen associations in the US that represent medical ...
Andrew Vaughan appointed CEN Sector Rapporteur Healthcare
The technical board at the European Committee for Standardization has appointed Andy Vaughan as CEN Sector Rapporteur Healthcare. Mr Vaughan's appointment was put forward by European medtech industry association Eucomed , where he is a consultant on ...
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