Quality/ Environmental Management

Certificates, CE declarations, information

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.


Please download file:

Safety data sheets (as of July 2016)

This CD-ROM provides a database including all current safety data sheets, operating instructions and list of substances, as well as further information.

Note:
When launching the database, please refer to the details provided in the operating instructions on the CD-ROM.
If you have any queries regarding the content of the safety data sheets, please contact our Safety Engineer Mr Michael Bonse by phone at +49 5527 848-1246.

Please download file:

RoHs-Declaration of Conformity Otto Bock HealthCare GmbH

This document contains a declaration of Conformity RoHS of Otto Bock Healthcare GmbH.

Please download file:

Declaration of Conformity RoHS Otto Bock Mobility Solutions GmbH

This document contains a declaration of Conformity RoHS of Otto Bock Mobility Solutions GmbH.

Please download file:

RoHS Declaration of Conformity Otto Bock Healthcare Products GmbH

This document contains a declaration of Conformity RoHS of Otto Bock Healthcare Products GmbH.

Please download file:

Declaration for materials and semi finished products of Otto Bock HealthCare GmbH

This document contains a delcaration regarding materials and semi finished products of Otto Bock HealthCare GmbH for use in medical devices.

Please download file:

ISO 13485 Quality Management System Otto Bock HealthCare LP

This document contains the certificate ISO 13485 : 2003.

Please download file:

DIN EN ISO 13485 Quality Management System Otto Bock HealthCare GmbH

This document contains the certificate DIN EN ISO 13485 : 2012 + AC : 2012.

Please download file:

DIN EN ISO 13485 Quality Management System Otto Bock Mobility Solutions Königsee GmbH

This document contains the certificate DIN EN ISO 13485 : 2012 + AC : 2012.

Please download file:

DIN EN ISO 13485 Quality Management System Otto Bock Healthcare Products GmbH Vienna

This document contains the certificate DIN EN ISO 13485 : 2012 + AC : 2012.

Please download file:

DIN EN ISO 14001 Environmental Management System

This document contains the certificate DIN EN ISO 14001 of Otto Bock Mobility Solutions Königsee GmbH.

Please download file:

CE declaration of conformity Otto Bock HealthCare GmbH

This document contains the CE declaration of conformity of Otto Bock HealthCare GmbH.

Please download file:

CE declaration of conformity of Otto Bock Mobility Solutions Königsee GmbH

This document contains the CE declaration of conformity of Otto Bock Mobility Solutions Königsee GmbH.

Please download file:

CE declaration of conformity Otto Bock Healthcare Products GmbH Vienna

This document contains the CE declaration of conformity of Otto Bock Healthcare Products GmbH Vienna.