Certificates
From 13th May, 2013 SoftSystem has established and applies certificates: ISO 9001:2015, PN-EN ISO 13485:2016-04 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.
PN-EN ISO 13485:2016
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 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.