List of Auditing Organizations (AO) recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR)

Latest Update: September 22, 2022

Auditing Organization (AO)

Contact Information

BSI America, Inc.

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) 291-5726

DEKRA Certification B.V.

DEKRA Certification B.V.

Meander 1051
Arnhem, 6825 MJ
Netherlands

Critical Locations:
North Wales, PA, USA
Concord, CA, USA

Claire Dyson
mdsap.nl@dekra.com
+44 (0)7703 735505

DNV GL Presafe AS

DNV GL Presafe AS
Veritasveien 1
Hovik, 1363
Norway

Zaher Kharboutly
zaher.kharboutly@dnvgl.com

+1 (416) 276-9525

DQS Med GmbH

DQS Medizinprodukte GmbH
August-Schanz-Str. 21
60433 Frankfurt am Main
Germany

Operating from
DQS Medizinprodukte GmbH
Konrad-Adenauer-Allee 8
D-61118 Bad Vilbel, Germany

Marc Goedecke
Marc.Goedecke@dqs-med.de
+49 69 95427-8107

Intertek Testing Services
North America Ltd.(ITS)

Intertek Testing Services NA Inc.
900 Chelmsford Street
Suite 301-3
Lowell, MA 01851 USA

Christine Forcier
Christine.Forcier@intertek.com
+1 514-378-6418

G-MED

G-MED
1, rue Gaston Boissier
75724 Paris, Cedex 15
France

Critical Locations :
St. Etienne, France
Bethesda, MD, USA

Béatrice Lys
beatrice.lys@lne-gmed.com
+33 (0)1 40 43 39 97

MedCert Zertifizierungs- und
Prüfungsgesellschaft für die
Medizin GmbH

MedCert Zertifizierungs- und
Prüfungsgesellschaft für die
Medizin GmbH
Pilatuspool 2
D-20355 Hamburg
Germany

Maxim Shkolnikov
msh@medcert.de
+49 40 2263325-390

National Standards Authority of Ireland (NSAI)

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

Pamela Burdette Miller
Pamela.BurdetteMiller@nsaiinc.com
+1 (603) 882-4412 (main office) and
+1 (603) 689-9148 (direct)

NCC Certificações do Brasil Ltda.

NCC Certificações do Brasil
Ltda. 233 Conceição St. - Suite 2511 Campinas, Sao Paulo 13010-916 Brazil

Wilson Bonato wilson.bonato@ncc.com.br
Tel. +55 19 99605 0397

QMI-SAI Canada Limited

QMI-SAI Canada Limited
20 Carlson Court, Suite 200
Toronto, ON, M9W 7K6

Alexander Crosby
Alexander.Crosby@intertek.com
+1 (800) 810-1195

SGS United Kingdom Ltd.

SGS United Kingdom Ltd.
Rossmore Business Park
Ellesmere Port, Cheshire
CH65 3EN

Timothy D. Gooch
timothy.gooch@sgs.com
+1 (256) 763-3099

TUV Rheinland of North America, Inc.

TÜV Rheinland of North America, Inc.
295 Foster St. Suite 100
Littleton, MA 01460
USA

Operating from :
TÜV Rheinland of North America, Inc.
1279 Quarry Lane, Suite A and C
Pleasanton, CA 94566
USA

Critical Locations:
Köln, Germany
Shanghai, China

Sebastiano Pane
Sebastiano.Pane@de.tuv.com
+1 (888) 743-4652

TÜV SÜD America Inc.

TÜV SÜD America Inc.
(also operating as TÜV America Inc.)
10 Centennial Drive
Peabody, MA 01960
USA

Critical Location:
Munich, Germany

Dawn Tibodeau
DTibodeau@tuvam.com
+1 651 638 0288
+1 651 638 0295

TUV USA, Inc.

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

UNDERWRITERS LABORATORIES, INC. (ULI)

UL Medical and Regulatory
Services UL, LLC
333 Pfingsten Road
Northbrook IL 60062-2096
USA

Operating from
UL, LLC
47173 Benicia Street
Fremont, CA
USA

Deborah L. Stubbs
Deborah.L.Stubbs@ul.com
+1 408-386-8399
+1 510-319-4173

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