• Application
• Supplement to the application
• The applicant shall be obliged
• Conducting the certification procedure

Ukrainian Certification Agency, certification authority accredited by National Accreditation Agency of Ukraine (NAAU), provides certification services for quality management systems for compliance with the requirements of various standards such as: ISO 13485: 2003 (DSTU EN ISO 13485:2015) “Medical devices. Quality control system. Regulatory requirements” and ISO 9001:2015 (DSTU ISO 9001:2015) “Quality management system. Regulations”

Accreditation Certificate No. 8О110 № 8О110

The main activity areas of Ukrainian Certification Agency in providing services on quality management systems certification for compliance with the requirements of ISO 13485 are the following economic sectors:

• inactive medical devices,
• active non-implantable medical devices,
• active implantable medical devices,
• medical devices for in vitro laboratory diagnostics,
• sterilization methods for medical devices,
• devices with special substances/technologies applied.

The main activity areas of Ukrainian Certification Agency in providing services on quality management systems certification for compliance with the requirements of ISO 9001 are the following economic sectors:

• 13 pharmaceutics,
• 29 wholesale and retail trade,
• 34 engineering services,
• 38 health and social work.

1.  ISO 9001
2. ISO 13485

The form of registration of complaints and appeals