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Medical devices : European Union policymaking and the implementation of health and patient safety in France
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Medical devices : European Union policymaking and the implementation of health and patient safety in France

Christa Altenstetter

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Contents

The European Union, France, and medical devices in context
The medical device industry in Europe and France
EU policymaking on medical devices
A new public health safety policy: the same old structural problems
More restructuring of state governance
Regulation in France
The Ministry of Health: a weak, low-status player
Negotiating the EU directives in Brussels, 1990-1998
From AdM to AFSSAPS
Implementing the IVD regulatory regime
Medical device vigilance
Local operations: regulations in the hospital
Conclusion and lessons learned.

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Medical devices : European Union policymaking and the implementation of health and patient safety in France by Christa Altenstetter. ISBN 9781412806909. Published by Transaction Publishers in 2008. Publication and catalogue information, links to buy online and reader comments.

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