Quality, Environmental Management
The Ottobock manufacturing sites are certified according to DIN EN ISO 13485. The current certificates that document the effective introduction and maintenance of QM systems can be downloaded here. Mobility Solutions GmbH is additionally certified according to DIN EN ISO 14001. The current certificate for the environmental management system can be found here. The CE declaration of conformity confirms the compliance of the Ottobock products with the statutory requirements under the medical devices directive 93/42/EEC. Relevant documents regarding the Ottobock manufacturing sites can be found on this page.
ISO 13485 Quality Management System Otto Bock HealthCare LP Salt Lake City | DownloadPDF | 0.4 MB |
DIN EN ISO 13485 Quality Management System Otto Bock HealthCare GmbH : 2010 | DownloadPDF | 0.4 MB |
DIN EN ISO 13485 Quality Management System Otto Bock Mobility Solutions Königsee GmbH : 2007 | DownloadPDF | 0.7 MB |
DIN EN ISO 13485 Quality Management System Otto Bock Healthcare Products GmbH Vienna | 2009 | DownloadPDF | 0.4 MB |
DIN EN ISO 14001 Environmental Management System | DownloadPDF | 0.1 MB |
CE declaration of conformity of Otto Bock Mobility Solutions Königsee GmbH | DownloadPDF | 0.1 MB |
CE declaration of conformity Otto Bock Healthcare Products GmbH Vienna | DownloadPDF | 0.3 MB |
DIN EN ISO 9001:2008 + ISO 13485:2012 Otto Bock Healthcare United Kingdom United Registrar of Systems Certification | DownloadPDF | 0.1 MB |
DIN EN ISO 9001:2008 + ISO 13485:2012 Otto Bock Healthcare United Kingdom United Registrar of Systems Certification Appendix | DownloadPDF | 0.1 MB |
DIN EN ISO 13485 : 2012 + AC : 2012 Quality Management System Otto Bock France : 2007 | DownloadPDF | 0.5 MB |
DIN EN ISO 13485_2012 Quality Management System Otto Bock Scandinavia : 2012 | DownloadPDF | 3.9 MB |
DIN EN ISO 13485 : 2012 + AC : 2012 Quality Management System Otto Bock China : 2012 | DownloadPDF | 0.4 MB |