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.
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
Quality Management System
Environmental Management System
93/42/EEC Directive
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MDD: |
EN 60601-1:2006+AC:2010+A1:2013 |
NAWI: EN 45501:2015 |
GM mark – Tested Medical Device label
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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.
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Medical scales with M-marking
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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.
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GOST-R Certificate
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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. |
SFDA Certificate
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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. |
