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):
- Questionnaire form GSTU ISO 13485
- Request 13485
- Request for verification of compliance with technical regulations
- List of documents 13485