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.

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 quality management related question, please contact our QMS & EMS Team:

E-mail: quality@digiterm.hu

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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

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.: INTERCERT 211586
Date of expiry: 14.09.2024

View Certificate

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

DO YOU HAVE QUESTIONS ABOUT OUR PRODUCTS?

We work as a united team around the world and give our clients the highest quality products and solutions possible. Our sales team will be happy to help you!

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