System Certification EN ISO 13485

System Certification EN ISO 13485

SINED is committed to quality since 1998, when it was first certified by TÜV SÜD certification body Product Service GmbH.
Now SINED is certified ISO 13485:2016.

EC Certification

certificate EC

Since 2013 the monitoring data collection software SINED EXPERT is the proud holder of the EC Certification Class IIb, for medical devices responding to the requirements of the 93/42/EEC Medical Devices Directive, Annex II.
The Certification has been released from the TÜV SÜD notified body Product Service GmbH (0123) of Munich.


LAP Certification

SINED MEDWARE® software is certified by “SGD Group” (worldwide leader in inspection, verification, analysis and certification services) for its hospital prescription support features, based on requirements settled on june 2012 by the French Healthcare High Authority (HAS).
This certification (“LAP”) guarantees the quality, safety, traceability and regulatory compliance of the prescriptions produced by SINED MEDWARE® software.