European Medical devices Reporting

European Medical devices Reporting

HOSPITAL: March 2007 10 questions on the medical device The medical device is intended to prevent the occurrence of serious incidents involving medical devices, through preventive or corrective action. The medical device is intended to monitor incidents or potential incidents resulting from the use of medical devices as defined in Article L.5211-1 of the Code of public health,says the article R.5212- 1 of the same code. These devices are equal to [...]


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Medical devices in European Union

Medical devices in European Union

How to define medical devices for in vitro diagnostic (IVD)? According to the Decree-Law n. 189/2 of 12 August, which transposes Directive 98/79/EC, DIV is: any medical device in vitro diagnostic which is a reagent, reagent product, calibrator, control material, assembly, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro analysis of samples from the human body with the [...]


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European medical devices approval

European medical devices approval

See all our services regulatory consulting and registration of medical devices . Emergo Group is a consultant serving the FDA regulation of medical device companies around the world seeking the approval of the Food and Drug Administration (FDA) to sell their products in the United States. For companies producing medical devices class II (and a small number of those in class I), one of the first steps is to submit a premarket notification, often referred [...]


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European medical devices market

European medical devices market

Emergo Group is a global company providing consulting services exclusively in Medical Device sanitary regulation, providing services exclusively to the medical device industry and In-Vitro Diagnostics (IVD). Here is link to pages that provide more information about our consulting services regulation of medical devices for different markets. Our consultants are located throughout the world so that, regardless of where you are located, we can provide [...]


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European medical device market 2011

European medical device market 2011

Reprinted from CSA Group websites Hong Kong, Aug. 1, 2013 / PRNewswire PRNewswire / - the world s leading testing and certification organization CSA Group companies with commercial standards BSI formed a strategic alliance for the electronic medical device industry (e-health) provide customers access to global markets solutions. Through the alliance, CSA Group will be based on relevant electronic standards for electronic medical product safety and [...]


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European Medical Devices Conference

European Medical Devices Conference

INTRODUCTION The Council of Europe has developed an international convention which is, for the first time, a binding legal instrument in the field of criminal law criminalizing counterfeiting but also the manufacture and distribution of medical products placed on the market without authorization or in violation of safety standards ( Convention MEDICRIME ). The Council of Europe has long been concerned about the lack of harmonized legislation at the [...]

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European medical devices definition

European medical devices definition

A medical device is an instrument, appliance, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and do not achieve their purposes through chemical action within or on the body. Whereas medicinal products achieve their principal action by pharmacological, immunological or metabolic, medical devices act by other means like physical, mechanical, or thermal. Medical devices [...]

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European Medical devices recalls

European Medical devices recalls

Many of Merck products for microbiology and microscopy are considered medical devices in vitro diagnostics (IVD), in accordance with directive 98/79/EC of the European Parliament and of the Council of 27 October 1998, fulfilling the requirements of CE mark. The detailed instructions for use of these products can be obtained by clicking on the link. In our section Microbiology , provide general instructions for the use of dehydrated culture media [...]

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