E-mail: ukrmedcert@ukrmedcert.org.ua
Work schedule Mon-Fri: 9:00 AM to 6:00 PM
Phone: +38 (044) 390-63-27
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"
Certification of the implemented QMS of MD production in accordance with the requirements of ISO 13485: 2016 "Medical devices. Quality Management System. Requirements for regulatory purposes"
Principles of the Conformity Assessment Body
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