Ministry for Development of Economy, Trade and Agriculture of Ukraine 
State enterprise "Kharkiv Regional Research and Production Center
for Standardization, Metrology and Certification"


Basic activities

Quality management systems for medical wares production

DSTU ISO 13485:2018

"Medical wares. Quality management systems. Regulating requirements."

 DSTU ISO 13485:2018  "Medical wares. Quality management systems. Regulating requirements." is the standard concerning the quality management systems in medical industry. It determines the quality management system requirements in those cases, when organization need to  show, that it can supply the medical instruments and render other services in accordance to the client’s requirements and corresponding normative requirements. Organizations have to stick to this standard when planning, developing, producing, installing, servicing and selling the medical instruments.
The DSTU ISO 13485:2018 primary goal is to facilitate the normative requirements harmonization, which act actually in relation to the quality management systems. In major part it is based on ISO 9001 standards, but also includes a number of certain requirements concerning the medical instruments, for example, risks analysis, sterile production and control possibilities.
 More detailed information according validity of the certificate for quality management system in the production of medical devices can be received by phone: (057) 756 38 05, E-mail:
Our contacts:
Contact details:
Department of quality and environment management  SE "Kharkivstandartmetrologiia"
40 Myronosytska Str,off.302, Kharkiv, 61002, Kharkiv, Ukraine
Tel./fax(38 057) 752-43-81
Tel./fax(38 057) 756-38-05
E - mail:
Head of department - Rogov Mikhail Feliksovich ​