Qualité garantit sécurité

Tous nos produits sont soumis à un système de contrôle interne. Dès la production jusqu'à l’envoi tous les produits sont contrôlés et vérifiés pour assurer leur qualité et fonctionnalité. Seulement des produits contrôlés quittent notre maison.

ISO 13485:2016

As one of the first companies, we have been certified according the latest version of ISO 13485:2016. We are proud to say that our quality management system has been found absolutely conform with the strict regulations of the latest version of ISO 13485:2016. These include:

  • an all-encompassing risk management covering all management systems
  • a stronger integration of the regulations 21 CFR part 280
  • an extended focus on feedback procedures
  • strict supplier control procesdures

The certifying body PUEG confirmed that we have consequently fulfil all requirements and regulations of ISO 13485:2016.

Initiates file downloadcertificate

Material resistance certificate
DIN EN 60068-2-74, DIN EN ISO 2409:2013

Our supports arms are resistant to all common disinfectants against multi-resistant bacteria (MRSA, klebisiella pneumonia, ESBL, clostridium difficile).
TREO Labor für Umweltsimulation - an accredited test laboratory for environmental simulation - has tested all components of our support arms with a variety of common disinfectants (Bacillol AF of Bode Chemie, B5 of Orochemie, SaniCloth AF3 of PDI Healthcare) and confirmed that no discolouration, abrasion nor any other material damage was found. Test specification and test parameters are conform with the regulations DIN EN 60068-2-74 (Fluid contamination) and DIN EN ISO 2409:2013 (Paint and varnishes - Cross cut test). 

Fraunhofer Tested Device

Easy one wipe cleaning.
Fraunhofer Institute has certified that our products can be easily disinfected by one-wipe cleaning.

Marquage CE

Les solutions de support de CIM sont marquées CE, sont conforme à la réglemention MDD 93/42/EEC et EN 60601-1, 3ième Edition.