Conformity Assessment Body

Evaluation of conformity of medical devices with the requirements of the Technical Regulations (753, 754, 755)

Assessment of QMS compliance with the requirements of ISO 13485: 2016 in the field of development, production, packaging, transportation and delivery of medical devices

Diagnostic audit of the current management system for the production of medical devices in accordance with the requirements of ISO 13485: 2016 "Medical devices. Quality Management System. Requirements for regulatory purposes"

Assessment of the correctness of the application of certain aspects of the Technical Regulations on medical devices.

Written confirmation of the extension of the action of the Technical Regulations on medical devices to certain products

Providing clarifications on the practice of applying the requirements of technical regulations in the field of circulation of medical devices

Apply

To apply for an assessment of the conformity of the system to quality management

To apply for the conformity assessment of products

If you have any questions, we will be happy to answer them, you just need to contact us via the feedback form and we will contact you during business hours, or call +38 (044) 390-63-27

Our certificates

If you have any questions, we will be happy to answer them, you just need to contact us via the feedback form and we will contact you during business hours, or call +38 (044) 390-63-27

Contacts

UKRMEDСERT LLC
02059, Ukraine, Kyiv,
1-А Drahomanova Street, office 2
Tel. +38 (044) 390 63 27
Email: ukrmedcert@ukrmedcert.org.ua

Feedback form

Address:
Kyiv,
1-А Drahomanova Street
02059

Work schedule
Mon-Fri: 9:00 AM to 6:00 PM

Phone:
+38 (044) 390-63-27

E-mail:
ukrmedcert@ukrmedcert.org.ua

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