Certificación del sistema de gestión de la calidad

Akreditovani in NAAU certification body LLC "Ukrainian Certification Agency" provides services on certification of quality management systems for compliance with various standards such as DSTU EN ISO 13485:2018 "Medical devices. The quality management system. The requirements for regulation" (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT), EN ISO 13485:2016 Medical devices -Quality management systems — Requirements for regulatory purpouse, ISO 13485:2016 Medical devices -Quality management systems — Requirements for regulatory purpouse)."

Certificate of accreditation No. 8О110

The main activities of LLC "Ukrainian Certification Agency" in the provision of services on certification of quality management systems for compliance the requirements of ISO 13485 are the following industries:

non-active medical devices;

active medical device which is implanted;

active medical products for implantation;

medical products for laboratory diagnostics in vitro;

sterilization methods for medical devices;

products in which the applied special materials/technologies.

The main activities of LLC "Ukrainian Certification Agency" in the provision of services on certification of quality management systems for compliance the requirements of ISO 9001 are the following industries:

13 pharmaceuticals;

38 health and social work.

ISO 9001

ISO 13485