Quality
All Oté products have the highest certification in order to have access to the markets of various countries. For all products, Oté has a certification in conformity with the Medical Device Directive (MDD 93/42/EEG) for access to the EU market and a certificate for the quality management system in accordance with ISO 13485 and NEN-EN-ISO 13485:2016. We also work in accordance with other guidelines, such as NEN-EN-ISO 13408-1.
Cleanroom
Oté products are filled in a cleanroom. This is a pure, controlled work environment in which the air is continuously filtered for microorganisms, fine particulates and any other air pollutants. This space is much cleaner than an operating room in a hospital.
In the factory
Certifications
Oté works with DEKRA Certification BV as a certification authority. DEKRA conducts the conformity assessment of both the quality system and the products of Oté under Notified Body number CE0344.