Certificates

Certificates

From 13th May, 2013 SoftSystem has established and applies certificates: ISO 9001:2008, PN-EN ISO 13485:2012 and PN-EN 62304:2010.

Successfully completed certification process is the result of SoftSystem Sp. z o.o. commitment in continuous improvement of product quality and meeting client requirements.

ISO 9001:2008

Scope of application:
Design, development and sales of software for medical institutions.

ISO 9001:2008

PN-EN ISO 13485:2012

Medical devices - Quality management systems - Requirements for regulatory purposes

Scope of application:
Design, development and production of medical devices in form of software applications which provide information for medical purposes based on in vitro examination of specimens derived from the human organism.

PN-EN ISO 13485:2012

PN-EN 62304:2010

Medical device software - Software life cycle processes

Scope of application:
Design, development and production of medical devices in form of software applications which provide information for medical purposes based on in vitro examination of specimens derived from the human organism.

PN-EN 62304:2010