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Regulatory Region - North America
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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 ...
INTERVIEW
In the industry's words
02 July 2010
On tenterhooks over the US Food and Drug Administration's reform of the 510(k) review process, the US medical technology industry is warning that the ...
LATEST FEATURES
Change Management and Quality Management: Ensuring a Change for the Better
07 July 2010
Brenda Percy explains why quality should be a part of change management throughout the whole product life-cycle and how to achieve this. Change is ...
In the industry's words
02 July 2010
On tenterhooks over the US Food and Drug Administration's reform of the 510(k) review process, the US medical technology industry is warning that the ...
Making a comeback after a negative experience with the US Food and Drug Administration
30 June 2010
Negative feedback from the US Food and Drug Administration does not necessarily mean disaster. Glenn Neuman tells companies how to get back on their ...
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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
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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