![]() Even though the Ukrainian DSTU ISO 13485:2015 is the analog of the international standard ISO 13485:2003, it is valid only on the Ukrainian territory. Its implementation is an indispensable prerequisite for the work on the market for medical products manufacturers and the necessary condition for conducting of the procedure of compliance with the Regulations. The Ukrainian analog for that international standard is DSTU ISO 13485:2015. That standard is used together with ISO 9001:2008 and GMP principles (good manufacturing practice). ![]() ISO 13485:2003 “ Medical devices – Quality management systems – Requirements for regulatory purposes” is the international standard, which regulates the creation and implementation of the quality management systems in the enterprises producing medical devices and equipment.
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