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An international vascular registry infrastructure for medical device evaluation and surveillance
Weill Cornell Med Coll, Dept Healthcare Policy & Res, New York, NY USA..
Dartmouth Hitchcock Med Ctr, Dept Surg, Lebanon, NH 03766 USA..
Univ Helsinki, Dept Vasc Surg, Helsinki, Finland.;Helsinki Univ Hosp, Helsinki, Finland..
Univ Utah, Div Vasc Surg, Salt Lake City, UT USA..
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2017 (English)In: Journal of Vascular Surgery, ISSN 0741-5214, E-ISSN 1097-6809, Vol. 65, no 4, p. 1220-1222Article in journal (Refereed) Published
Abstract [en]

The Medical Device Epidemiology Network (MDEpiNet) is an innovative effort supported by the US Food and Drug Administration (FDA) that is committed to the development of a medical device science and surveillance infrastructure. Recently MDEpiNet sponsored a national medical device registry task force which developed a guidance document for 21st century medical device evaluation that highlights the importance of national and international registries, their linkages with other relevant data, and stakeholder involvement. 1 Two international efforts, the International Consortium of Orthopedic Registries (ICOR) and the International Consortium of Cardiovascular Registries (ICCR) 2 were launched in the past 4 years to study orthopedic and cardiovascular devices in this regard.

Place, publisher, year, edition, pages
MOSBY-ELSEVIER , 2017. Vol. 65, no 4, p. 1220-1222
National Category
Surgery Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:uu:diva-326516DOI: 10.1016/j.jvs.2017.01.020ISI: 000402625400041PubMedID: 28222986OAI: oai:DiVA.org:uu-326516DiVA, id: diva2:1129588
Available from: 2017-08-04 Created: 2017-08-04 Last updated: 2017-08-04Bibliographically approved

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Björck, Martin

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