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. Critical Location |
Morgan Quandt Morgan.quandt@bsigroup.com +1 571 443 1708 |
Yes | Yes | Yes |
 |
DEKRA Certification B.V. Critical Locations |
Adriano Mulloni mdsap.nl@dekra.com +31 88 96 83408 |
Yes | Yes | Yes |
 |
DNV Product Assurance AS Veritasveien 1 Hovik, 1363 Norway |
Zaher Kharboutly zaher.kharboutly@dnv.com +1 416 276 9525 |
Yes | Yes | No |
 |
DNV MEDCERT GmbH Pilatuspool 2 D-20355 Hamburg Germany |
Maxim Shkolnikov Maxim.Shkolnikov@dnv.com +49 40 2263325-390 |
Yes | Yes | No |
 |
DQS Medizinprodukte GmbH Operating from |
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. 900 Chelmsford Street Suite 301-3 Lowell, MA 01851 USA |
Christine Forcier Christine.Forcier@intertek.com +1 514-378-6418 |
Yes | Yes | Yes |
 |
G-MED Critical Locations |
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@ncc.com.br Tel. +55 19 99605 0397 |
Yes | Yes | No |
 |
National Standards Authority of Ireland Operating from: |
Denise Woodward Denise.Woodward@nsaiinc.com +1 (603) 882-4412 (main office) and +1 (308) 870-5543 (direct) |
Yes | Yes | Yes |
 |
QMI-SAI Canada Limited 20 Carlson Court, Suite 200 Toronto, ON, M9W 7K6 |
Alexander Crosby Alexander.crosby@intertek.com +1 (800) 810-1195 |
Yes | Yes | No |
 |
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. Operating from: Critical Locations |
Sebastiano Pane Sebastiano.Pane@de.tuv.com +1 (888) 743-4652 |
Yes | Yes | Yes |
 |
TÜV SÜD America Inc. Critical Location |
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 Operating from |
Chiranjit Deka, Ph.D chiranjit.deka@ul.com +1 919-208-4704 |
Yes | Yes | Yes |