Quality & Certifications

Our technologies for health... Your success! 

Quality and safety are of great importance at KitoZyme. By anticipating and valuing our management, we want not only to effectively respond the customer's requirements, but also go beyond them in term of value and certifications. In this context, we have implemented an integrated Management System for the continuous progress of our products.

We believe that nothing can be achieved without continual improvement. KitoZyme is committed to a process of continuous performance improvement

KitoZyme delivers high-quality products by following the requirements of:

KitoZyme operates a Quality Management System which complies with the requirements of ISO 13485 : 2003 & EN ISO 13485 : 2012 for the scope : Development, production and distribution of medical devices based on polymers of natural origin for oral and topical applications.

  • The Quality Management System meets the applicable requirements stated in the Medical Devices Directive 93/42/EEC in order to obtain the notification
  • Our auto-control system (SAC) is certified by the Belgian authorities -Federal Agency for the Safety of the Food Chain - FASFC- for the production of nutraceutical and beverage ingredients
  • KitoZyme has implemented the HACCP system (Hazard Analysis and Critical Control Point)