Certification & CE MARKING

ISO 13485 certification

Quality is one if the priority objectives of the company. That is why Cosmosoft is ISO 13485 certified.
The manufacture and commercialisation of medical devices is subject to regulatory standards. To respond to this, Cosmosoft has set up a quality system. This system has been certified according to ISO 13485: 2016. This international standard for quality management
systems specifies the particular requirements of quality management systems for the medical devices.

Cosmosoft certified ISO 13485 2016 Kiwa

CE marking

ReduStim and ReduStim SP devices developed as medical devices comply with Directive 93/42 / EC and have a CE marking issued by a notified body (EC 0476).

These devices comply with the following standards:

– IEC 60601-1-2: 2014 electrical compatibility; IEC 60601-1: 2005 + A1: 2012;IEC 60601-1-6: 2010 + A1: 2013.

– Electrical safety IEC 60601-1: 2005 + CORR. 1: 2006 + CORR. 2: 2007 + AM1: 2012.