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 )

 

 

 

 

 

Medical Device Regulation

 

 

The new Medical Device Regulation, 2017/745 (MDR) took effect in the EU on 26th of May 2021. All medical devices falling under Class I. must comply with the MDR from day one. Most of our chairs belong to this group.

 

It is our pleasure to inform you that Digiterm has finished the preparation phase and is now MDR compliant. Our EUDAMED registration is available by clicking the below link:

 

https://ec.europa.eu/tools/eudamed/#/screen/search-eo/48329088-01c4-49f8-bb92-187b32e6d16d

 

As an effect of the registration some changes will be visible on the labels of the chairs. These will contain the UDI-DI identifier of the chair type and the denomination of the chair on the local language of the destination.

 

As of the end of May the MDR compliant updated User Manuals will also be available.
Please do not forget to inform us if you need alternative language for the documentation.

 

Important notice!

 

Our C3 Scale and C4 Scale chairs are classified as Class Im. Class Im products must comply with the MDR regulations by May 26th, 2024. The C3 Scale and C4 Scale chairs can be marketed until this time using the certifications issued under the 93/42/EEC (MDD) directive, so they are not affected by the transition to the MDR at this moment.

 

While delivering safe and high quality seating solutions globally, the satisfaction of our partners always was and will be key value for us.

 

If you have any questions regarding this newsletter, please contact our QMS & EMS Leader:

 

Gábor VARGA
Tel: +36 37 311 990
Mobile: +36 30 119 0067
E-mail: gabor.varga@digiterm.hu

 

 

 

 

 

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.: 145037
Date of expiry: 03.09.2023

 

EN ISO 13485:2016 Quality Management System
Reg. No.: 145036
Date of expiry: 03.09.2023

 

 

 

 

 

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

 

 

 

 

 

GM mark – Tested Medical Device label

 

 

 

This product certificate and test mark goes above and beyond the standard legal requirements. It certifies that additional product testing has been done by a Notified Body including regular product site inspections and technical documentation reviews. It proves that our medical devices offer the highest standard of quality and safety.

 

 

 

 

 

 

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.: LR-202012-C-1149–SFDA-9501
Date of expiry: 15.12.2023

 

 

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