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In vitro diagnostics in medicine and veterinary medicine: basic concepts and difference.

Posted on Monday March 28th, 2022 by beawireA

In recent years, clinical laboratory diagnostics have received a big leap in their development, whose is the main task detection or confirmation of pathology that would be impossible refuted or confirmed by organoleptic methods. In vitro diagnostics are carried out using various biological fluids, such as whole blood, plasma, serum, sputum, cerebrospinal fluid, etc. The process of conducting clinical laboratory

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Toxicology tests for in vitro diagnostics

Posted on Monday August 17th, 2020 by beawire

Toxicology tests for medical devices intended for in vitro diagnostics are to be performed in order to determine any possible harmful effect of a material or device on the human body, caused by a toxicity factor. These tests have to be performed for medical devices intended for immediate contact with the human body, when used as per the intended indications

What we do?

Posted on Monday April 6th, 2020 by beawire

How we help manufacturers to join Russian market? See our video

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About us

Posted on Sunday April 5th, 2020 by beawire

Company BW, LLC is consulting agency for medical device and IVD product registration. Every day we develop technical documentation, which is compliant to Russian regulations and requirements. Our team supports whole cycle of registration from translation to sample import and testing arrangements. For each registration process are involved up to 7 specialists, each of the specialist is in charge of

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In vitro diagnosis of autoimmune diseases

Posted on Thursday October 3rd, 2019 by beawire

Autoimmune diseases (AID) develop in cases where antibodies (AT) or T cell clones are present in the body, directed against the body’s own antigens (AG). Autoimmune mechanisms are at the heart of many organo-specific and systemic diseases. These diseases include rheumatoid arthritis, insulin-dependent diabetes mellitus, ulcerative colitis and other less known diseases. The resulting autoimmune process is usually chronic and

Orphan diseases

Posted on Thursday September 26th, 2019 by beawire

According to the All-Russian Society of Orphan Diseases, about 30 million patients with rare diseases were registered in the European Union. This means that every 15th European suffers from one or another orphan disease. The figures are impressive, given that the synonym for orphan diseases is “rare diseases”. Federal Law 323 states that orphan disease is a disease the prevalence

CAR-T therapy

Posted on Friday November 23rd, 2018 by beawire

In the section devoted to biomedical cell products, much attention was paid mainly to the legal aspects of the circulation of this type of product, as well as to the basic procedures that make up the life cycle of BMCP. However, this article is devoted directly to BMCP – the newest and promising method of treatment of cancer, in particular

Telemedicine in Russia – review

Posted on Thursday August 9th, 2018 by beawire

Russian Federation is the biggest country in the world by territory and it looks like telemedicine could be solution for connection healthcare specialists and patients. We started special topic about this: Why telemedicine is important as healthcare service? How it is regulated by government? Which products is considered to be medical devices for telemedicine? This is not full range of

Labeling of active medical devices

Posted on Monday April 23rd, 2018 by beawire

In one of the previous articles we discussed necessary symbols, that must contain label of medical devices for state registration in Russia. Today we present symbols, that must contain label of active medical devices. They are presented in the Table 1. Table 1 – Necessary symbols Power source parameters 1. Power (I or P) Consuming current or power GOST R

Medical device labeling

Posted on Friday April 6th, 2018 by beawire

Today we speak about some easy but necessary rules in Russia – labeling, marking of medical devices must comply with in order to medical device could be registered in Russian Federation. Should be noticed, that all the labeling rules (except the electrotechnical symbols) are regulated by 3 standards: GOST R 50444, GOST R ISO 15223 and GOST 14192. The last

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