Os Organismos Auditores listadas abaixo são acreditados pelo sistema de avaliação de conformidade cadadense (Canadian Medical Devices Conformity Assessment System – CMDCAS) e são elegíveis para apresentar uma candidatura ao Piloto do Programa de Auditoria Única em Produtos para Saúde (MDSAP – sigla em inglês). Organismos Auditores Elegíveis Situação: Acreditado Em: 2001-02-08 Situação: Acreditado Em: 2009-04-06 Situação: Acreditado Em: 2011-01-24 Localidade Contato BSI Group America Inc. (also operating under BSI Inc.) 12950 Worldgate Drive, Suite 800, Monument II Herndon, VA 20170 USA http://www.bsigroup.com/en-US/ Reg Blake [email protected] Vice President, Corporate Development and Regulatory Affairs +1 703 464 1908 +1 703 437 9001 DEKRA Certification B.V. Meander 1051 Arnhem, 6825 MJ Netherlands http://www.dekra.com/en/home Brent Anderson [email protected] Senior Program Manager +1 925 283 7535 DQS Medizinprodukte GmbH August-Schanz-Strasse 21 Frankfurt am Main, D-60433 Germany http://www.dqs-medizinprodukte.de/en Maxim Shkolnikov [email protected] Product Manager +49 69 95427-236 +49 69 95427-6236 Situação: Acreditado Em: 1993-02-02 Situação: Acreditado Em: 2004-07-27 Situação: Acreditado Em: 1997-09-12 Situação: Acreditado Em: 2003-12-31 Intertek Testing Services NA Ltd. trading as Intertek 1829, 32nd Avenue Lachine, QC H8T 3J1 Canada http://www.intertek.com Paula Oddy [email protected] Americas Technical Manager +1 616 656 0630 Laboratoire National de métrologie et d'Essais (LNE) - Division certification G-MED (trading as LNE/G-MED and G-MED) 1, rue Gaston Boissier 75724 Paris, Cedex 15 France http://www.gmed.fr Corinne Delorme [email protected] Regulatory Affairs +33 1 40 43 39 72 +33 1 40 43 37 37 Lloyd's Register Quality Assurance Inc. 1330 Enclave Parkway, Suite 200 Houston, TX 77077 USA http://www.lrqausa.com Krissi Temple [email protected] Quality Manager +1 281 398 7370 +1 281 398 7337 National Standards Authority of Ireland 1 Swift Square Northwood, Santry Dublin, 9 Ireland http://www.nsai.ie Tom Costelloe [email protected] Quality Officer +353 0 61 200 943 +353 1 807 3844 SAI Global Certification Services Pty Ltd. 680 George Street Level 37-38 Sydney, NSW 2000 Australia http://www.saiglobal.com/ Guillaume Gignac [email protected] Vice President, Corporate Operations, Accreditation and Quality +1 416 401 8653 +1 416 401 8650 SGS United Kingdom Ltd. Inward Way, Rossmore Road Ellesmere Port, Cheshire CH65 3EN Chris Jepson [email protected] Product Certification Manager +44 1934 522 917 +44 1934 522 137 Situação: Acreditado Em: 2008-09-10 Situação: Acreditado Em: 2007-08-28 Situação: Acreditado Em: 2013-03-11 Situação: Acreditado Em: 2003-03-20 Operating from: Unit 202B, Worle Parkway Weston Super Mare, Somerset BS22 6WA United Kingdom http://www.sgs.co.uk/ TÜV NORD CERT GmbH Langemarckstr. 20 45141 Essen, Germany http://www.tuv-nord.com/en/serv/certification-412.htm Udo Kubitz [email protected] Head of Department for International Certification + 1 49 201 825 33 TUV Rheinland of North America, Inc. North American Headquarters 1300 Massachusetts Ave., Suite 103 Boxborough, MA 01719 USA http://www.tuv.com/en/usa/home.jsp Brian Ludovico [email protected] Certification Manager +1 978 266 9500 ext. 234 +1 978 266 9992 Situação: Acreditado Em: 2001-08-03 TÜV SÜD America Inc. (also operating as TÜV America Inc.) Management Service Division 10 Centennial Drive Peabody, MA 01960 USA http://www.tuv-sud-america.com/ Gary Minks [email protected] Vice President, Quality & Regulatory Affairs +1 978 573 2500 +1 978 977 0157 TÜV USA, Inc. 215 Main Street, Suite 3 Salem, NH 03079 USA http://www.tuv-nord.com/us Michael Hopkins [email protected] President +1 603 870 8023 +1 603 870 8026 UL LLC 333 Pfingsten Road Northbrook IL 60062-2096 US Mark van de Waterlaat [email protected] Engineering Manager +31 26 376 4985 +31 26 376 4840 Situação: Acreditado Em: 2013-03-18 Situação: Acreditado Em: 2001-12-12 Operating from: 455 East Trimble Road San Jose, CA 95131-1230 USA http://www.ul.com
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