№ | Document Title | Download (language) | ||
1. | Application for Conformity assessment of medical devices to Technical regulations. | Укр | Рус | Eng |
2. | Appendix to Application for Conformity assessment of medical devices to Technical regulations. | Укр | Рус | Eng |
3. | Appendix to Application for Conformity assessment of medical devices to Technical regulations for IVD medical devices. | Укр | Рус | Eng |
4. | Application for Conformity assessment of medical devices to Technical regulations due to changes. | Укр | Рус | Eng |
5. | Questionnaire for Conformity assessment of medical devices to Technical regulations. | Укр | Рус | Eng |
6. | Example of filling in the Application for Conformity assessment of medical devices to Technical regulations | Укр | Рус | Eng |
7. | Application for recognition of conformity assessment of medical devices to Technical regulations. | Укр | Рус | Eng |
8. | Application for recognition of conformity assessment of medical devices to Technical regulations, Change. | Укр | Рус | Eng |
9. | Declaration of conformity (information) | Укр (md) | Укр (ivd) | |
10. | Application for Quality system certification according to ISO 9001 | Укр | Рус | Eng |
11. | Questionnaire for Quality system certification according to ISO 9001 | Укр | Рус | Eng |
12. | Application for Quality system certification according to ISO 13485 | Укр | Рус | Eng |
13. | Questionnaire for Quality system certification according to ISO 13485 | Укр | Рус | Eng |
14. | Application for certification of quality management systems, changes | Укр | Рус | Eng |
15. | Application for performance of tests | Укр | Рус | Eng |
16. | Order for consideration of appeals petitions and complaint | Укр | Рус | Eng |
17. | Use the name of the certification body and the certification mark or logo | Укр | Рус | Eng |
18. | National mark of conformity SE "UMCC" | Укр | Рус | Eng |