Certifications

System Certification EN ISO 13485

certificate ISO

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.

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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.

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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.

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Certificazione DataDock

French law of 5th of march 2015 gave the lenders of professional training the responsibility of checking the training organizations with which they operate.
In order to improve the quality of the training offer, the Law defined six evaluation criteria, to be applied on each Entity applying for the subscription to the single national database managed by lenders(“DataDock”), gathered in “GIE D2OF” (Economic group which manages DataDock).
After the registration on DataDock the Training Entities must provide evidence demonstrating their compliance to the twentyone quality indicators, defined by Lenders belonging to GIE D2OF.
After these checks, the Entity evaluated as compliant becomes “datadocké”.
Since 2017 every training intervention can be funded only if provided by a “datadocké” Entity.
Since June 2017 SINED has proven its compliance to quality indicators, gaining DataDock Certification.

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