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Maintenance of the Procedure for Assessing the Conformity of Medical Devices


PE «POLITOKS» carries out work on certification of the management system for compliance with the requirements of the standards: ISO 13485: 2016, DSTU EN ISO 13485: 2015, DSTU ISO 13485: 2005.

Application forms and the list of required documents are given below..

List of documents (in Ukrainian):

  1. Questionnaire form GSTU ISO 13485
  2. Request 13485
  3. Request for verification of compliance with technical regulations
  4. List of documents 13485

List of documents (in English):

  1. Questionnaire form GSTU ISO 13485 (2012)
  2. Questionnaire form GSTU ISO 13485 (2016)
  3. Request 13485
  4. Request for verification of compliance with technical regulations
  5. List of documents 13485

The rules for using the certification mark of a management system certified by the state-accredited conformity assessment body, «POLITOKS»

(in Ukrainian)



Rules of using the certification system sign of a management system certified by the Conformity Assessment body of PE «POLITOKS»

(in English)

  1. Questionnary ISO 13485 (2012)
  2. Questionnary ISO 13485 (2016)
  3. List of Documents ISO 13485
  4. Application form 13485
  5. Application form TR Politox