Tag Archives: Head

Medical device test – electromagnetic compatibility

Electromagnetic compatibility (EMC) is the modern concept that combines such popular electromagnetic phenomena as radio interference, effects on the network, overvoltage, voltage fluctuations in the network, electromagnetic influences, grounding effects, etc. In recent decades, there has been a rapid growth in the development of medical electrical products and systems. EMC for medical devices (MD) can be defined as “the ability

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Readability test.

As mentioned in our last article, within the framework of bringing the dossier into compliance with the requirements of the EAEU, it may be necessary to provide the patient leaflet (PL) and the results of readability test (more on this: https://beawire.com/ru/2020/09/21/procedure-for-bringing-the-registration-dossier-in-line-with-the-requirements-of-the-eaeu/). In this article we will try to elaborate on the readability test and the necessary format of its provision.

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Centella asiatica in perfumery and cosmetic products.

  Centella asiatica is an unremarkable plant growing in tropical regions of Asia, Oceania, Africa and America. Centella leaves, or gotu cola (“fountain of youth”), are applied in Chinese and Indian traditional medicine to treat ulcers, swelling, wound healing. In addition, there is evidence that the centella extract contributes to the improvement of cognitive functions in neurodegenerative disorders. Currently, Centella asiatica

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What is EDC and what does it have to do with cosmetics?

EDC (Endocrine disrupting chemicals) – chemicals that destroy the endocrine system (a system of glands that make hormones). Currently, a team of European Union experts classified approximately 150 substances as EDCs. Surprisingly, representatives of this group of substances can still be part of food, plastic packaging and cosmetic products. What compounds are included in EDC? How dangerous are they? And

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What are weight-loss dietary supplements and what do they do?  

The proven ways to lose weight are cutting calories, eating healthful foods and being physically active.  But making these lifestyle changes isn’t easy. In this regard, eating weight loss supplements is a common way to combat excess weight. This article will consider the most common ingredients included in the composition of dietary supplements, as well as their benefits and harms.

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Complicated medical device

We face both “complex” and “simple” products in the course of work. Let’s clarify what we mean by these concepts. A “complex” product is: – a product incorporating many elements, each of which requires a detailed description in the technical and operational documentation; – highly engineered product; – a product in compliance with international safety standards, possibly even widely distributed

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Marketing authorization of Medical Devices for aviation in Russia

Marketing authorization of Medical Devices (MD) for aviation and the registration procedure for “conventional” medical devices are different.  The main difference is the special aspects of the technical tests. First of all, the types of medical devices should be determined that can be used on aircraft. The list of medical devices and medicinal products that can be provided to civil

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The first license for production of BMСP was obtained.

The first license for production of BMСP was obtained. Licensing of BMСP production was one of the key problems in bringing such products to the Russian market. We have published several articles covering the requirements for the applicant of the license (https://beawire.com/ru/biomedical-cell-products/licensing-of-biomedical-cell-products-production-activities/https://beawire.com/ru/biomedical-cell-products/licensing-of-biomedical-cell-products-production-activities/), as well as the success of some companies in licensing the production of BMСP (https://beawire.com/ru/2019/04/08/bmcp-problems-and-prospects-of-development-in-russia/). According to the

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