AO contact details
Information is provided here on AOs available to conduct audits of medical device manufacturers under the MDSAP, including the status of their authorization to conduct MDSAP audits, and their recognition.
Recognition: AOs that are fully recognized to conduct MDSAP Audits, in contrast to those that are authorized and are in the process of recognition.
Authorized to conduct MDSAP Audits: AOs authorized to perform MDSAP audits, and MDSAP RAs will accept their reports/certificates although not fully recognised as MDSAP AOs. This ‘authorized’ step is necessary for ANVISA to accept reports prior to formal recognition.
Further information on the difference between ‘Authorized’ and ‘Recognized’ is available here.
| Eligible Auditing Organization | Location | Contact Status |
|---|---|---|
| BSI Group America Inc. Critical Location | Morgan Quandt Application Received: Yes |
| DEKRA Certification B.V. Critical Locations | Chris Stephens Application Received: Yes |
| DNV Product Assurance AS Veritasveien 1, Hovik, 1363 Norway | Zaher Kharboutly Application Received: Yes |
|
| DNV MEDCERT GmbH Pilatuspool 2, D-20355 Hamburg Germany | Heike Nolte Application Received: Yes |
| DQS Medizinprodukte GmbH Operating from | Marc Goedecke Application Received: Yes |
| IMQ S.p.A. Via Quintiliano, 43 20138 Milan (MI) Italy | Cecilia Cantaluppi Application Received: Yes |
| Intertek Testing Services NA Inc.
| Christine Forcier
|
| GMED Critical Locations | Béatrice Lys Application Received: 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 | Guisla Martins Application Received: Yes |
| National Standards Authority of Ireland Operating from: | Denise Woodward Application Received: Yes |
| SGS United Kingdom Ltd. Rossmore Business Park Ellesmere Port, Cheshire CH65 3EN | Tamara Nichols Application Received: Yes |
| TÜV Rheinland of North America, Inc. Critical Locations | Sebastiano Pane Application Received: Yes |
| TÜV SÜD America Inc. Critical Location | Dawn Tibodeau Application Received: Yes |
| TUV USA, Inc. (TÜV NORD Group) 215 Main Street Salem, NH 03079 USA | Bradley Chen Application Received: Yes |
| UL LLC Operating from | Chiranjit Deka, Ph.D Application Received: Yes |