The security and safety issues have been one of the main directives towards o3 Enterprise moved since its foundation. The challenge that the company has faced has been combining two concepts that in theory are each other's opposite: the open source model and the medical device world!

The company worked a lot for several years in this direction and finally in 2010 o3 Enterprise gained the ISO 13485 certification!

The certificates are the following:

The ISO 13485 is "an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices ." (from Wikipedia).

This means that all the software developed by o3 Enterprise is covered by the CE MARK.

The certificates has been issued by SIQ, the Slovenian Istitue of Quality and Metrology.