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When to do This procedure is gradually becoming a thing of the past, but still requires clarification. It is a process that requires updating the current data in the registry and reissuing...

Labeling of medical devices is one of the most important stages of production. This is how the consumer gets all the necessary information about the product and the manufacturer, and how to...

On every package of a medical product, we can always see a line with the expiration (storage) date or the issue date and expiration date and can calculate this value ...

It is probably unnecessary to say that regulation in different areas of activity may differ greatly from country to country - it is obvious. In each country or region...

Every product goes through the same stages from idea to utilization. Some products are more complex, some simpler, but in general, the same sequence is followed. Even...

Many manufacturers believe that the life cycle of an MI ends at the stage of obtaining a registration certificate. However, it should not be forgotten that there are a number of ...

Pharmacovigilance is a set of activities aimed at detecting and preventing various incidents on the market related to the use of medical devices...

Why is a registration dossier collected? The main material for studying product safety is the registration dossier. And its correct compilation is the key to...

To answer this question, we first need to refer to the Health Code and other Orders that define the term. In the Code there is a...

What are technical specifications for a medical device? So, let's first understand the difference between technical specifications and an organization's standard. Technically, it is about...