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.

File	Download
Safety data sheets (as of March 2021)	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. ManualPDF \| 441 KB Database for safety data sheetsZIP \| 6.6 MB If you have any questions about the content of the material safety data sheets, please contact the department safety and environmental (Arbeitssicherheit@ottobock.de)
REACh regulation	Information obligation according to article 33 in REACh regulation (EG Nr. 1907/2006) Otto Bock Mobility Solutions GmbHPDF \| 113 KB
RoHs-Declaration of Conformity	RoHs-Declaration of Conformity Ottobock SE & Co. KGaAPDF \| 167 KB RoHS Declaration of Conformity Otto Bock Healthcare Products GmbHPDF \| 209 KB
RoHs Declaration of Conformity	RoHS Declaration of Conformity Otto Bock Mobility Solutions GmbHPDF \| 180 KB
RED Declaration of Conformity Otto Bock Healthcare Products GmbH	RED Declaration of Conformity Otto Bock Healthcare Products GmbHPDF \| 1.1 MB
Declaration for materials and semi finished products of Ottobock SE & Co. KGaA	Declaration for materials and semi finished products of Ottobock SE & Co. KGaAPDF \| 175 KB
DIN EN ISO 13485 Quality Management System	DIN EN ISO 13485 Quality Management System Ottobock SE & Co. KGaAPDF \| 578 KB DIN EN ISO 13485 Quality Management System Otto Bock Mobility Solutions GmbH - Effective date: 2020-07-17PDF \| 814 KB DIN EN ISO 13485 Quality Management System Otto Bock Mobility Solutions GmbHPDF \| 773 KB DIN EN ISO 13485 Quality Management System Otto Bock Healthcare Products GmbHPDF \| 723 KB
CE declaration of conformity	CE declaration of conformity Ottobock SE & Co. KGaAPDF \| 140 KB CE declaration of conformity of Otto Bock Mobility Solutions GmbHPDF \| 169 KB CE declaration of conformity Otto Bock Healthcare Products GmbHPDF \| 4.8 MB