Skip to content Skip to navigation menu

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