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About us
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
Read moreIn vitro diagnosis of autoimmune diseases
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
Read moreOrphan diseases
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
Read moreCAR-T therapy
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
Read moreTelemedicine in Russia – review
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
Read moreLabeling of active medical devices
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
Read moreMedical device labeling
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
Read moreSPRS-therapy
Nowadays the market for biomedical cell products (BMCP or BCP) is a rapidly growing branch of the global economy. This is due to the fact that this type of product provides a fundamentally new approach to the treatment of many diseases: malignant neoplasms, cardiovascular diseases, diseases of the nervous system and musculoskeletal system, as well as diabetes mellitus. BMCP is
Read moreThe number of stomatology material samples for biocompatibility studies
In one of previous articles we discuss quantity of medical device samples for toxicological testing (biocompatibility trials). Current article is about necessary number of stomatology (dental) material samples for toxicological testing. The standard regulated this quantity in Russia is GOST 31576. And its actual version is GOST 31576-2012. The 3rd section of these standards contain the table, regulating the necessary number
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