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Pubmed for Handhelds

PUBMED FOR HANDHELDS

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  • Title: Clinical evaluations clinical investigations under the amended Medical Device Directive.
    Author: Dannhorn DR, Schwabedissen H.
    Journal: Med Device Technol; 2008 Sep; 19(5):16-8, 20. PubMed ID: 18947145.
    Abstract:
    Directive 2007/47/EC1 amends the earlier Medical Device and Active Implantable Medical Device Directives. Amongst its new requirements is the need for more clinical data and more frequent clinical investigations in the conformity assessment of innnovative medical devices. Details of the changes and the implications for manufacturers are outlined.
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