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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.

ISO 9001:2015

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

PN-EN ISO 13485:2016-04

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.

DIN EN ISO/IEC 27001:2017

An Information Security Management System according to “Statement of Applicability”

Scope of application:

Research, design, production and sale of IT Solutions.