Rusatom Metal Tech LLC (The Integrator of Rosatom's Fuel Company TVEL in the metallurgical sector) has participated as a standholder and an expert of the business program in the IV All-Russian Forum Circulation of NOVAMED-2024 medical devices, which ended on November 15 in Moscow.
Among other participants of the event are the representatives of relevant ministries, experts of Federal Service for Surveillance in Healthcare, VNIIIMT Federal State Budgetary Institution subordinate to Roszdravnadzor, Federal State Independent Institution Institute of Standardization subordinate to Rosstandart, RusAccreditation, The Eurasian Economic Commission and the business Community.
In the framework of the exhibition, Rusatom Metal Tech LLC presented key medical products for traumatology and orthopaedics: sheets and nails for external and internal osteosynthesis, made from titanium alloy and stainless steel, and surgical instruments for their installation.
The business program of the forum was devoted to the discussion of the issues of state policy in the field of development, production and circulation of medical devices. Andrey Andrianov, CEO of Rusatom Metal Tech LLC, shared his experience of primary inspection of production and obtaining registration certificates for medical devices. He has noted, that certification has become an important stage prior to start-up of production Rosatom Implant LLC, where implants for external and internal osteosynthesis will be produced from titanium alloy and stainless steel, as well as surgical instruments required for their installation. "Our products are produced with the use of close-control and high-performance equipment, ensuring compliance with international quality standards. Our products will cover 80% of of the needs of domestic medical and preventive treatment facility for implants of certain designation and standard sizes, which accounts for about 30% of the needs of the entire Russian market of implanted devices for osteosynthesis. By having our own source of raw materials and sophisticated technologies, we managed to localize full-cycle production from semi-finished product to finished product, not only implants, but also the entire range of surgical installation instruments for traumatology. Moreover, we are not only able to provide medical and preventive treatment facilities with sets of the instruments, but also with services for repair and replacement in timely manner," Andrey Andrianov highlighted.
It was noted that technical, toxicological and clinical trials have already been successfully performed, and compliance of the quality management system with the requirements applicable to manufacturers of medical devices has been confirmed.
"Reduction of term for launching medical devices to market is a key task that requires close cooperation between manufacturers, healthcare professionals, the regulator and investors. The comprehensive service "Single Window" is a support tool for manufacturers for reduction of term for launching medical devices to market, and it also allows to prepare the production site for the inspection. The Scientific council of experts provides the preparation of consensus in solving issues related to the registration of medical devices" Igor Ivanov, General Director of VNIIIMT Federal State Budgetary Institution subordinate to Roszdravnadzor, said.
Reference
Rosatom's Fuel Division (Rosatom's Fuel Company TVEL) includes enterprises for the manufacture of nuclear fuel, uranium conversion and enrichment, production of gas centrifuges, as well as scientific research and design organizations. Being the sole supplier of nuclear fuel for NPP in Russia, TVEL supplies fuel to a total of more than 70 power reactors in 15 countries, research reactors in nine countries, as well as transport reactors for the Russian nuclear fleet. Every sixth power reactor in the world operates with TVEL fuel. Rosatom's Fuel Division is the largest manufacturer of enriched uranium in the world, as well as the leader of the stable isotope global market. Under Rosatom's Fuel Division, new businesses in the fields of chemistry, metallurgy, energy storage technologies, 3D printing, digital products, as well as decommissioning of nuclear facilities are actively developing. In Rosatom State Corporation network, Rosatom's industry integrators for additive technologies and energy storage systems have been established. http://www.tvel.ru
Rusatom Metal Tech LLC is divisional integrator of Rosatom's Fuel Company TVEL in the metallurgical sector. Fuel Company metallurgical business development objectives include, in particular, the expansion of the customer base in Russia and abroad, the development of productive capacity, the establishment of new alliances and partnerships. Among technological partners of Rusatom Metal Tech LLC are enterprises, which specialize in the manufacture of high-melting point metals and light metals, as well as alloys based on them. The integrator consolidates the responsibilities of TVEL enterprises in the metallurgical sector: Chepetskiy Mechanical Plant, ELEMASH Machine-Building Plant, Novosibirsk Chemical Concentrates Plant, ELEMASH MAGNIT, NPO CENTROTECH LLC. The scientific potential, technological skills, and qualified personnel of enterprises allow to perform work on large-scale production.
In 2022, medical materials and technologies sector was set apart as an independent business under the divisional metallurgical integrator of Rosatom's Fuel Division. Activities of business area of medical materials and technologies is devoted to the design, development and production of implants for external and internal osteosynthesis and surgical instruments for their installation and replacement. The main aim of the area is to increase accessibility for the medical facilities in high-quality domestic implants and instruments, needed to perform surgeries.
Russian companies successfully implement development projects and create innovative solutions. The development of emerging technologies increases the competitiveness of both the nuclear industry and the domestic economy as a whole. Rosatom and its enterprises are actively participating in this work.
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