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. ( QMS, MDR, TQM, FMEA, LEAN )





Quality Management System



In order to reach our aims ISO 9001:2015 for product and services quality and EN ISO 13485:2016 especially for the quality of medical products are being maintained.


Conformance with the requirements of the standards is beeing audited regularly.


ISO 9001:2015 Quality Management System
Reg. No.: 144781
Date of expiry: 06.09.2020


EN ISO 13485:2016 Quality Management System
Reg. No.: 144782
Date of expiry: 06.09.2020




Environmental Management System



The management of Digiterm Ltd. declared its commitment – in compliance with the requirements of ISO 14001:2015 Standard – toward the continuous development of environmental performance and prevention of pollution.


Conformance with the requirements of the standards is beeing audited regularly.

ISO 14001:2015 Environmental Management System
Reg. No.: 181586
Date of expiry: 14.09.2021






93/42/EEC Directive




Digiterm Ltd. registered as a manufacturer of medical devices by Authority for Medical Devices of Hungarian Ministry of Health. (Reg. No.: 35780/2001)

All of our products comply with EU standard regulation belongs to EC declaration and entitled to use the CE mark.


The COMFORT Therapy chairs comply with the requirements of Decree 93/42/EEC for medical installations and the other standards applied:


EN 1041:2008
EN ISO 10993-1:2009+AC:2010
EN ISO 10993-5:2009

EN 60601-1:2006+AC:2010
EN 60601-1-2:2007+AC:2010
EN 60601-1-6:2007
EN 60601-2-52:2010
EN 62366:2008

NAWI: EN 45501:2015
RoHS: EN 50581:2012





Medical scales with M-marking





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 is beeing tested and certified regularly.





Safety tested products


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

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

Certificate No. I 600 82343






GOST-R Certificate



Digiterm Ltd. as a manufacturer of medical devices also registered by the Russian Ministry of Health. (Reg. No.: F33 2012/11522)


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. IM 24 N Q5939


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