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:

 

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

EN 60601-1:2006+AC:2010+A1:2013
EN 60601-1-2:2015
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.

 

 

 

 

 

 

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

 

 

 

 

 

SFDA Certificate

 

 

Digiterm Ltd. as a manufacturer of medical devices is also registered by the Saudi Food and Drug Authority. ( Reg. No.: M00370 )

 

The authorisation allows to market the Comfort chairs in the Kingdom of Saudi Arabia.
Certificate is issued in accordance with the Medical devices interim regulation (MDIR) and in particular to the implementing rule MDS-IR6 for Medical Device Marketing Authorisation (MDMA).

Certificate No.: MDMA18070421
Date of expiry: 26.02.2021

 

 

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