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:
Research, design, production and sale of IT solutions.
PN-EN ISO 13485:2016
Medical devices – Quality management systems – Requirements for regulatory purposes
Scope of application:
Design and development of computer software providing information for medical purposes based on in vitro diagnostics of specimens derived
from the human body at the request of other manufacturers of medical devices.
PN-EN 62304:2010
Medical device software – Software life cycle processes
Scope of application:
Design and development of computer software providing information for medical purposes based on in vitro diagnostics of specimens derived from the human body at the request of other manufacturers of medical devices.
EN-ISO/IEC 27001:2023
An Information Security Management System according to “Statement of Applicability”
Scope of application:
Research, design, production and sale of IT Solutions.
