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. 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.
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Safety data sheets (as of October 2020) | File">This download provides a database including all current safety data sheets, operating instructions and list of substances, as well as further information. Note: Please download the zip-file locally to your PC and unzip the file. The unzipped file contains the “sumdat” folder with the SDS-Database. Please don’t open the “sumdat” folder without unpacking the zip-file. It leads to problems opening the database. Manual Database for safety data sheets If you have any questions about the content of the material safety data sheets, please contact the department safety and environmental (Arbeitssicherheit@ottobock.de) | Download">
REACh regulation | File">Information obligation according to article 33 in REACh regulation (EG Nr. 1907/2006) Otto Bock Mobility Solutions GmbH | Download">
RoHs-Declaration of Conformity | File"> RoHs-Declaration of Conformity Ottobock SE & Co. KGaA RoHS Declaration of Conformity Otto Bock Healthcare Products GmbH | Download">
RoHs Declaration of Conformity | File">RoHS Declaration of Conformity Otto Bock Mobility Solutions GmbH | Download">
RED Declaration of Conformity Otto Bock Healthcare Products GmbH | File">RED Declaration of Conformity Otto Bock Healthcare Products GmbH | Download">
Declaration for materials and semi finished products of Ottobock SE & Co. KGaA | File">Declaration for materials and semi finished products of Ottobock SE & Co. KGaA | Download">
DIN EN ISO 13485 Quality Management System | File"> DIN EN ISO 13485 Quality Management System Ottobock SE & Co. KGaA DIN EN ISO 13485 Quality Management System Otto Bock Mobility Solutions GmbH - Effective date: 2020-07-17 DIN EN ISO 13485 Quality Management System Otto Bock Mobility Solutions GmbH DIN EN ISO 13485 Quality Management System Otto Bock Healthcare Products GmbH | Download">
CE declaration of conformity | File"> CE declaration of conformity Ottobock SE & Co. KGaA CE declaration of conformity of Otto Bock Mobility Solutions GmbH CE declaration of conformity Otto Bock Healthcare Products GmbH | Download">