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  1. Medical Device Single Audit Program (MDSAP)

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.

Eligible
Auditing
Organization
Location Contact Application
Received
Authorized
to Conduct
MDSAP
Audits
Recognition
BSI Group America Inc. Logo

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. Logo

DEKRA Certification B.V.
Meander 1051
Arnhem, 6825 MJ
Netherlands

Critical Locations
Concord, CA, USA
Stuttgart, Germany

Adriano Mulloni
mdsap.nl@dekra.com
+31 88 96 83408
Yes Yes Yes
Logo for DNV Product Assurance AS
DNV Product Assurance AS
Veritasveien 1
Hovik, 1363
Norway
Zaher Kharboutly
zaher.kharboutly@dnv.com
+1 416 276 9525
Yes Yes Yes
Logo for DNV MEDCERT GmbH
DNV MEDCERT GmbH
Pilatuspool 2
D-20355 Hamburg
Germany
Heike Nolte
Heike.Nolte@dnv.com
+49 40 2263325-229
Yes Yes No
Logo for DQS Medizinprodukte GmbH

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
Logo for IMQ S.p.A.
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. Logo

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 Logo

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. Logo
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@ncc.com.br
Tel. +55 19 99605 0397
Yes Yes No
National Standards Authority of Ireland Logo

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. Logo
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. Logo
            

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. Logo

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) Logo
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 Solutions Logo

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
 
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