EU 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.
Actor ID/SRN : HU-MF-000004201
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.
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 quality management related question, please contact our QMS & EMS Team:
E-mail: quality@digiterm.hu
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.: C603179
Date of expiry: 03.09.2026
View Certificate
ISO 13485:2016 Quality Management System
Reg. No.: 145207
Date of expiry: 06.09.2026
View Certificate
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.: 24081586KIR
Date of expiry: 14.09.2027
View Certificate
FDA Device Registration and Listing
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Digiterm’s products fall into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, therefore a premarket notification application and FDA clearance is not required before marketing the device in the U.S.
However, as a manufacturer, it must register its establishment: |
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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. Authorization number: MDMA-1-2018-1153 |
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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 |
