In 2022, RITM OKB ZAO passed a number of planned certification audits. As a result, all international certificates for the quality and safety of SCENAR devices were successfully renewed.
RITM OKB ZAO has become one of the few companies worldwide that have passed a high-level verification for compliance with the EU Medical Device Regulation MDR 2017/745 requirements. The new Regulations turned out to be much more demanding than the previous MDD ones. The auditors paid particular attention to the risk analysis, clinical evaluation, and safety of medical devices. As a result of a successful assessment, the CE mark (the EU quality management system certificate) was obtained, which signifies that our products meet the safety, health, and environmental protection requirements of the EU, and can be marketed worldwide.
In December 2022, RITM OKB ZAO received the renewed ISO 9001 and 13485 certificates (international quality management standards, where the 1st applies to organizations across industries, and the 2nd – to the medical device industry). GCERTI Co.Ltd., the accredited international certification body recognized the company’s quality management system as complying with international standards.
Also, last year RITM OKB ZAO confirmed the quality of SCENAR devices according to the US, Mexico, and South Korea requirements, and received the relevant certificates and permits. The auditors assessed the total product life cycle including development and modernization, manufacturing processes, sanitary control, maintenance, storage, and user interaction and training procedures.
Despite the complicated international political and economic situation, RITM OKB ZAO products are in high demand, and we continue to successfully export them to the world market. Our devices are registered and represented in 36 countries including but not limited to: the US (FDA), Israel, Mexico, Australia, Russia, etc..