Certifications

Stendo Laboratoire® is ISO 13485 and ISO 9001 certified

STENDO has put in place a quality system to meet current regulatory standards governing the manufacture and sale of medical devices. This system is audited by SGS and has been certified as compliant with ISO 9001:2008 and ISO 13485:2003 standards.

ISO 13485 and ISO 9001 are international standards relating to quality management systems. The ISO 13485 standard specifies the specific requirements for quality management systems relating to the medical devices industry.

Download certificates :
ISO 9001
ISO 13485

CE marking

The Stendo device developed for non-medical applications, is compliant with the CE marking for electrical devices.
The system is compliant with the following standards :
a) Electromagnetic Compatibility EMC
Directive 2004/108/EC, 2004 EMC ; EN IEC 60601-1-2:2007
a) Electrical Safety
The product has been tested to the IEC 60601-1:2005 standard

The tests were performed by the laboratory LCIE (Veritas)

The medical version of the STENDO device is subject to the medical devices directive 93/42/EC and should receive the relevant CE marking sometime in 2016, after an audit by a notified body: No. 0120 SGS.

Brands and patents

Brands and patents filed worldwide.