Turnkey Organization of Medical Device Production
Launching medical device (MD) production in Russia is a complex, multi-stage process requiring deep expertise in regulation, technology, and project management. Elibrium offers a full cycle of services for organizing production within the Russian Federation, providing legal and technical support at every stage — from concept to obtaining industrial manufacturer status.
We will handle all issues related to localization and launch of your enterprise.
1. Pre-Project Analysis and Equipment Procurement
Production success is built at the planning stage. Our specialists conduct a thorough audit of requirements for your future production line. We assist with equipment cost estimation, selection, and procurement, as well as sourcing necessary materials and components. Our goal is to ensure economic efficiency and technological feasibility of your project from the very beginning.
2. Technical Documentation Development and Production Preparation
We don't just supply equipment — we ensure its full integration into the production process. This stage includes:
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Drafting technical specifications (TS) for production and equipment installation.
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Installation and comprehensive commissioning of the production line.
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Development and optimization of technological processes to ensure stable and high-quality output.
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Development of all necessary technical and operational documentation, including manuals, regulations, and product passports.
3. Staffing and Training
Medical device production requires highly qualified personnel. Elibrium selects and trains staff specifically for manufacturing your MD in compliance with all quality and safety requirements. We transfer knowledge and skills to your team to ensure smooth operations from day one.
4. Registration and Administrative Support
Entering the medical device market requires navigating all bureaucratic procedures. Our team has years of experience in the industry's regulatory framework. We provide:
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Medical device registration in accordance with the new requirements of Government Decree of the Russian Federation No. 1684.
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Interaction with government authorities at all stages, including Roszdravnadzor and the Ministry of Industry and Trade.
5. Enterprise Launch and Obtaining Russian Manufacturer Status
The final stage of our partnership is the full launch of your enterprise with all necessary permits. We accompany the process through:
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Actual commissioning of the enterprise.
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Obtaining the Ministry of Industry and Trade conclusion confirming production of industrial products on the territory of the Russian Federation in accordance with Government Decree No. 719.
This conclusion is key for participation in government procurement and confirms your product's status as Russian-made, granting access to state support measures and preferences.
Advantages of Working with Elibrium
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Systematic approach: We cover all stages — from material procurement to obtaining the Ministry of Industry and Trade conclusion.
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Deep expertise: Up-to-date knowledge of the requirements of Government Decree No. 1684, Government Decree No. 719, and EAEU regulations.
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Practical experience: We understand the specifics of launching and equipping medical device production facilities.
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Quality control: At every stage, we guarantee that the developed documentation and technologies comply with strict standards.
Elibrium is your reliable partner in creating modern, certified medical device production in Russia.
