Quality & Safety

Our main target is building Customer satisfaction through the Quality of our Products and Services.

Our quality engineering, like the rest of the organisation is completely dedicated to customer satisfaction by continuous improvement in products and processes. ( ISO 9004:2000, TQM, FMEA )

Quality Management System

In order to reach our aims EN ISO 9001:2000 + EN ISO 13485:2003 Quality Management System are being maintained.

Environmental Management System

The management of Digiterm Ltd. declared its commitment - in compliance with the requirements of EN ISO 14001 Standard - toward the continuous development of environmental performance and prevention of pollution.

93/42/EEC Directive

EN 294:1992
EN 349:1993
EN 980:1996
EN 1441:1997
EN ISO 10993-1:1997
EN 60601-1:1990

EN 60601-2-38:1996
EN 60601-1-2:1993
EN 55011:1998
EN 61000-3-2:1995
EN 61000-3-3:1995
EN 61000-4-2:1995

EN 61000-4-3:1996
EN 61000-4-4:1995
EN 61000-4-5:1995
EN 61000-4-6:1996
EN 61000-4-8:1996
EN 61000-4-11:1994

In accordance with the relevant regulation, the EC verification of a medical scale has to be fulfilled in the place of installation because it depends on the reference value of gravity in the zone.

Manufacturing process of Weight Measurement System has been tested and certified by TÜV Rheinland Product Safety Gmbh as a Notified Body.

High quality and outstanding safety features of our products are being inspected by TÜV Rheinland Product Safety GmbH.

GM mark (Geprüftes Medizinprodukt - Approved medical device) certify the compliance of requirements of relating standards besides the controlled production conditions.

Certificate No. I 60002510

Digiterm Ltd. as a manufacturer of medical devices also registered by the Russian Ministry of Health. (Reg. No.: 2002/16)

The Comfort Therapy chairs are tested by SGS International Certification Services S. A. and justified the compliance of relating Russian standards on the GOST-R certificate.

Certificate No. POCC HU. AE68. B 13077