notified body


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notified body

A private institution charged by a competent authority with verifying compliance of medical devices (not drugs) with the applicable Essential Requirements stated in the Medical Devices Directive; this process, called Conformity Assessment, has EU-wide validity once completed by the notified body.
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Because the certification process for American machinery manufacturers looking to sell machinery to Europe can be "a tricky business, filled with unknowns," according to the WMMA newsletter, American woodworking machinery manufacturers seeking a notified body agent in the United States or in Europe are advised by the WMMA to contact Charles Ludolph, of the Office of European and Regional Affairs with the U.
Connie O'Connor, Notified Body auditor for DEKRA Certification, B.
DBI Certification is a notified body under Construction Products Regulation and Marine Equipment Directive.
A notified body is a European Union ("EU") accredited third party authorized to conduct reviews and audits of medical device companies and their devices.
Among other things, the unit DEKRA Rail is a Notified Body for the EC conformity assessment (TSI) in Europe.
Labeling scrutiny has become more intense and, according to Notified Body auditors, "major non-conformities are being written for insufficient translation procedures.
9, 2013 /PRNewswire/ -- Bruin Biometrics, LLC ("BBI") an innovative medical device manufacturer, announced today that it has received ISO 13485:2003 and EN ISO 13485:2012 certification, including CMDCAS certification, for its Quality Management System with its notified body SGS.
Qualification and assignment of notified body assessment personnel, including MDD-QMS auditors, product assessors and product specialists;
The Industry Service division also provides Notified Body services through its parent organization TouV SouD Group, a Notified Body for the PED and TPED, and other EU Directives.
19-91100 (Amz); 20-91100 (Bpmz); 21 91100 (BMZ) Series passenger wagons adaptation of the design and manufacturing processes associated with restructuring conducted by one registered in the European Union Notified Body (Notified Body) of the EC verification procedure.
Establishing the laboratory in Tampere is a part of SGS Fimko's and the SGS Group's development plan for testing, certification and Notified Body services in medical device sector.
Effective immediately, TE[pounds sterling]V SE[pounds sterling]D Danmark is now a Notified Body which assesses compliance with interoperability requirements.