Services

Applying European approaches and being guided by the impartiality principle in our activity, we offer the following services:

  • Assessment of conformity of medical devices to technical regulationsView;
  • Certification of management systems to confirm conformity to the requirements ofView:
    • DSTU ISO 9001: 2009 Quality management systems. Requirements (ISO 9001:2008 Quality management systems. Requirements, ISO 9001:2008 Quality management systems – Requirements).
      N.B.!
      Institutions delivering secondary and tertiary health care and claiming the highest accreditation category shall have a certificate of conformity of the quality management system to the requirements of the national standard DSTU ISO series 9001. Absence of the certificate may be a basis for denial of assignment of the highest accreditation category to the institution.
      ECOHYNTOX CAB carries out certification of quality management systems of health care institutions, including primary health care institutions, regardless of their ownership form, in accordance with Resolution of the Cabinet of Ministers of Ukraine No. 121 dated 17.12.2012.
    • DSTU ISO 13485:2005 Medical devices. Quality management systems. Requirements for regulatory purposes (ISO 13485:2003, IDT);
    • ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes;
    • DSTU EN ISO 13485:2015 Medical devices. Quality management systems. Requirements for regulatory purposes (EN ISO 13485:2012, IDT);
    • EN ISO 13485:2012 Medical devices – Quality management systems – Requirements for regulatory purposes;
    • DSTU ISO 22000:2007 Food safety management systems. Requirements for any organizations in the food chain.

 

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