Medical Device
Contract Manufacturing
Contract manufacturing provides significant optimization of costs and timing for expansion into foreign markets and, in particular, into the Russian market, and consequently it supports optimized prime cost and the shortest possible time for products to entry into the marketplace. There is no need to build an enterprise building, supply the necessary communications and commissioning, obtain a license for the production site, search for personnel, conduct all accompanying activities that ensure the competent operation of the industrial platform.
Antaross LLC provides outsourcing services for the production of medical devices, starting with the development and preparation of documentation, finishing with the production of final products and their registration with the health authorities.
Our manufacturing stands out from others for the qualification of engineers and the ISO 13485 quality management system. Each of our engineers has a specialized education in the field of production and maintenance of medical equipment, which is confirmed by diplomas. All of them also constantly take upgrade training courses. The implementation of the ISO 13485 quality management system allows us to reduce manufacturing defects to zero and eliminate any risks associated with the human factor.
If you have an idea of a medical device, but have no own production, we can design and manufacture it for you, we can act as a production site, we can confirm the place of production for Roszdravnadzor and external audit.
DEVELOPMENT
OF MEDICAL DEVICES
The medical industry is one of the most science-based industries, therefore, the development of new medical devices should be carried out by professionals with both technical and medical knowledge
WE ARE OPEN TO COOPERATION AND OFFER THE FOLLOWING SERVICES FOR THE DEVELOPMENT OF MEDICAL DEVICES:
- Development of medical device design;
- Design, 3D modeling of the layout and construction of a medical device;
- Manufacture of prototypes of medical devices (or parts thereof);
- Creation and testing of prototypes of medical devices and their packaging;
- Organization of production processes;
- Development of documentation;
- Product registration;
- Serial production.
Medical equipment software
development
Software development and data analysis is one of our key strengths.
We are specialized in manufacturing of software for medical equipment on any operating system or without it. We develop the interface design, plan out the software architecture, algorithms, link the software with the peripherals.
LOCALIZATION OF
MEDICAL EQUIPMENT
- We provide localization services for medical devices in Russia. A number of medical devices manufactured outside the EAEU countries are prohibited to purchase by state and municipal institutions in the Russian Federation. More than 80% of the Russian market of medical devices accounts for the public sector. Priority in public procurement is given to goods produced in Russia. Therefore, it becomes profitable and interesting for foreign manufacturers of medical devices to localize their products in the Russian Federation. We offer foreign manufacturers, as well as their partners in Russia, a full range of services for manufacturing localization of medical devices in the Russian Federation.
REGISTRATION OF MEDICAL EQUIPMENT
IN THE MINISTRY OF HEALTH
We provide services for the registration of medical devices according to national rules and the new rules of the EAEU. Registration of medical devices in Roszdravnadzor is a necessary condition for their placing on market, namely import, sale and production in Russia.
Testing support during the registration process:
- Toxicological tests;
- Technical tests;
- Clinical tests.
AND WE WILL DEVELOP A CUSTOMIZED SOLUTION FOR YOU!
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