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Инженерный центр Медицинские изделия и Техника

IC Miit is a company that exclusively specializes in providing consultation for medical instruments and equipment. It further provides its service by assisting in registration and documentation of their health care devices. It is a Russian based firm that's been helping convert potential ideas of products into workable medical devices ready for market distribution. For more information please visit https://ic-miit.ru/

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Инженерный центр Медицинские изделия и Техника

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  1. Engineering Center Medical Products and Equipment-Providing Easy Quick Services There's an evolution of the Russian medical device registration procedure. If you would like to market a medical device in the current market, you have to register. IC MIIT has exceptional experience, and their expertise has helped many customers to register their products. The register for a medical device it takes to follow some steps. One has to prepare for documents such as a technical document, instruction reports, and certification, and the IC MIIT Company can help you in the procedure. The technical and clinical tests should be run in the Russian federation. Similarly, many occasions sterilizers also have ISO 13485 certifications for sterilization services. ISO 13485 is a voluntary benchmark for the EU, so it's a harmonized standard en ISO 13485 2012, but it may be necessary by other medical devices regulatory authorities. For example, ISO 13485 2003 is required to advertise the device in Canada. ISO 13485 is not a law or regulation; however, it's mandatory to get a medical device. Whether you would like to expand locally or function internationally, ISO 13485 certificates help eliminate uncertainty and enhance overall performance and dedication to quality. When Assessing medical devices, every medical device can be attributed to only one class: category 1 - medical devices with a low degree of risk; class 2a - medical apparatus with an average degree of risk; class 2b medical apparatus with an increased degree of risk, class 3 medical devices with risk at a higher degree. Belonging to in vitro diagnostic devices and the Amount of materials in contact with the patient. For more information please visit https://ic-miit.ru/ When classifying medical apparatus, the conditions of use and functional purpose are taken into account. The following criteria include the whole period of usage of medical devices, the invasiveness of medical devices, the presence of contact of medical devices together with the human body, or even the connection with it. The also includes the way of introducing medical devices to the human body through anatomical cavities or surgically and the medical apparatus for critical organs and organs such as heart, central circulatory system, central nervous system, and energy sources.

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