Tag Archives: medicaldevices

Blockchain technology in medicine

Blockchain technology (BT) became popular with the development of cryptocurrency bitcoin in 2009. From that moment on, interest in this invention began to take place in many sectors of the economy, including medicine. In this review, we will try to explain as simple as possible what blockchain is and how it can be applied in the fields of medicine and

Read more

Mobile medical technologies

The title of this article does not coincidentally sound “mobile medical technologies”, and not “mobile medical devices”. This material is devoted not only to medical devices, but also to technologies that do not have the status of “medical device” in the Russian Federation, but are intended for medical purposes. To date, it is mainly apps on mobile phones, smartwatches and

Read more

Telemedicine technologies in the modern healthcare system.

During the COVID-19 pandemic, sectors of the economy such as education and health are particularly digitalized. Of course, it cannot be said that the current situation was a reason for the development of information technologies, but significantly contributed to the involvement of a large number of people in the transition to remote format of work. In this regard, telemedicine technologies

Read more

What in the composition of a drug can be considered a medical device in national regulation system?

With the development of technologies and the integration of “physics” and “chemistry” a variety of products , which are no longer drugs in the form of classic dosage forms (tablets, ointments, etc.), but the whole systems of delivery of a medicinal substance come into the pharmaceutical market. Such systems involve the use of auxiliary elements that may prove to be

Read more

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

Read more

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

Read more

Features of increasing the shelf life of a medical device in case of making amendments to the registration documents

Introduction The shelf life of a medical device determines the period during which the product retains its functional properties and technical specifications established by the manufacturer. After the state registration of a medical device in the territory of the Russian Federation, the established value of the shelf life can be changed in accordance with the Decree of the Government of

Read more

Fast track registration for products from special list

Expecting to have special registration process for some medical device products. Order of Russian Government 1416 latest updates bring these changes – for limited list of products: medical devices with 1 risk class are included in this list (for example, gloves), “fast track” includes initial submission with very limited amount of documents – with providing main dossier after registration certificate

Read more
« Older Entries