Medical devices : European Union policymaking and the implementation of health and patient safety in France / Christa Altenstetter.

New Brunswick, N.J. ; London : Transaction Publishers, [2008], ©2008.

xxxii, 270 pages : illustrations ; 24 cm

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.

Includes bibliographical references (p. 243-260) and index.

"Government documents": p. 261-265.