Auditing Organization Availability to Conduct MDSAP Audits

The organizations listed below submitted an application to the Medical Device Single Audit Program (MDSAP). The table specifies their status regarding their application, their authorization to conduct MDSAP audits, and their recognition.

Location	Contact	Application Received	Authorized to Conduct MDSAP Audits	Recognition
BSI Group America Inc. 12950 Worldgate Drive, Suite 800, Herndon, VA 20170 USA Critical Location Milton Keynes, UK	Morgan Quandt Morgan.quandt@bsigroup.com +1 571 443 1708	Yes	Yes	Yes
DEKRA Certification B.V. Meander 1051 Arnhem, 6825 MJ Netherlands Critical Locations Stuttgart, Germany	Adriano Mulloni mdsap.nl@dekra.com +31 88 96 83000	Yes	Yes	Yes
DNV Product Assurance AS Veritasveien 1 Hovik, 1363 Norway	Zaher Kharboutly zaher.kharboutly@dnv.com +1 416 276 9525	Yes	Yes	Yes
DNV MEDCERT GmbH Pilatuspool 2 D-20355 Hamburg Germany	Heike Nolte Heike.Nolte@dnv.com +49 40 2263325-229	Yes	Yes	No
DQS Medizinprodukte GmbH August-Schanz-Strasse 21 D-60433 Frankfurt am Main Germany Operating from DQS Medizinprodukte GmbH Konrad-Adenauer-Allee 8 D-61118 Bad Vilbel, Germany	Marc Goedecke marc.goedecke@dqs.de Tel: +49 69 95427-8107	Yes	Yes	Yes
IMQ S.p.A. Via Quintiliano, 43 20138 Milan (MI) Italy	Cecilia Cantaluppi Cecilia.Cantaluppi@imq.it Tel.: +39 02 5073 317	Yes	Yes	No
Intertek Testing Services NA Inc. 4700 Broadmoor Ave SE, Suite 200 Kentwood, MI 49512 USA www.intertek.com	Christine Forcier Christine.Forcier@intertek.com +1 514-378-6418	Yes	Yes	Yes
G-MED 1, rue Gaston Boissier 75724 Paris, Cedex 15 France Critical Locations St. Etienne, France Rockville, MD, USA	Béatrice Lys beatrice.lys@lne-gmed.com +33 (0)1 40 43 39 97	Yes	Yes	Yes
NCC Certificações do Brasil Ltda. 360 Orosimbo Maia Avenue, Suites 101 to 114 and 211 to 215 Zip Code 13.010-211 Campinas, São Paulo, Brazil	Wilson Bonato wilson.bonato@bureauveritas.com Tel. +55 19 99605 0397	Yes	Yes	No
National Standards Authority of Ireland 1 Swift Square, Northwood, Santry, Dublin 9, Ireland D09 A0E4 Operating from: NSAI, Inc. 20 Trafalgar Square, Suite 603 Nashua, NH 03063 USA	Denise Woodward Denise.Woodward@nsaiinc.com +1 (603) 882-4412 (main office) and +1 (308) 870-5543 (direct)	Yes	Yes	Yes
SGS United Kingdom Ltd. Rossmore Business Park Ellesmere Port, Cheshire CH65 3EN	Tamara Nichols Tamara.Nichols@sgs.com +1 (859) 304-3063	Yes	Yes	Yes
TÜV Rheinland of North America, Inc. 400 Beaver Brook Road Boxborough, MA 01719 USA Critical Locations Köln, Germany Shanghai, China Yokohama, Japan Zabrze, Poland	Sebastiano Pane Sebastiano.Pane@de.tuv.com +1 (888) 743-4652	Yes	Yes	Yes
TÜV SÜD America Inc. (also operating as TÜV America Inc.) 401 Edgewater Place, Suite 500 Edgewater Technology Park Wakefield, MA 01880 Critical Location Munich, Germany	Dawn Tibodeau Dawn.Tibodeau@tuvsud.com +1 651 638 0288 +1 651 638 0295	Yes	Yes	Yes
TUV USA, Inc. (TÜV NORD Group) 215 Main Street Salem, NH 03079 USA	Bradley Chen bchen@tuv-nord.com +1 603 870 8023 +1 844-4 TUV USA	Yes	Yes	Yes
UL LLC, UL Solutions medical regulatory services 333 Pfingsten Road Northbrook IL 60062-2096 USA Operating from UL LLC 12 Laboratory Drive Research Triangle Park, NC 27709 USA	Chiranjit Deka, Ph.D chiranjit.deka@ul.com +1 919-208-4704	Yes	Yes	Yes