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We received the certificates guaranteeing that Neurosoft Company meets the requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and apply the system of quality assurance for our system manufacture stages and product test. After having received these certificates we have a right of drawing CE mark on the following systems:

This is a significant event in our company's life. Now our production can be sold on international markets where CE certificate is required. This is the successive step of the quality system formation. The next step will be the enlargement of the number of digital systems certified according to European requirements.

Publication date: February 6, 2007

Other news concerning this topic

[11:15] March 9, 2011


We Obtained EC-Certificate for our Devices Compliance to IIb Class Requirements

We certified our devices for compliance to IIb class requirements according to Annex II of Council Directive 93/42/EEC of 14 June 1993 “Concerning Medical Devices”.

Now Neurosoft Company equipment can be used in operating rooms and intensive care units of medical establishments of European Community.

Details

[10:34] August 12, 2008


We received the certificate guaranteeing that Neurosoft Company meets the requirements of Council Directive 93/42/EEC of 14 June 1993 concerning the medical devices and applies the quality assurance system for the production and the final inspection of the portable all-in-one ABR, DPOAE & TEOAE hearing screening system Neuro-Audio-Screen.

Details

[10:19] April 24, 2008


We received the certificate confirming that Neurosoft сompany products: digital EEG and EP systems Neuron-Spectrum-1, Neuron-Spectrum-4/P and Neuron-Spectrum-4/EPM correspond to Directive 93/42/EEC.

Details

[17:29] February 5, 2007


We received the certificate guaranteeing that Neurosoft Company meets the requirements of Council Directive 93/42/EEC of 14 June 1993 concerning the medical devices and applies the quality assurance system for the production and the final inspection of the digital neurophysiological system for EEG, EP and EMG Neuron-Spectrum-5.

Details

[09:50] June 14, 2006


We received the certificate guaranteeing that Neurosoft Company meets the requirements of Council Directive 93/42/EEC of 14 June 1993 concerning the medical devices and applies the quality assurance system for the production and the final inspection of the magnetic stimulator Neuro-MS.

Details

[15:21] March 7, 2006


We received the certificates guaranteeing that Neurosoft Company has a right of drawing CE mark on digital ECG systems Poly-Spectrum-8, Poly-Spectrum-8/E, VNS-Rhythm and VNS-Micro.

Details

October 25, 2005


Neurosoft Company gained the certificates of conformance to International standards DIN EN ISO 9001:2000 (full standard) and DIN EN ISO 13485:2003 instead of the acted earlier certificates of conformance DIN EN ISO 9001:2000 (exception is the engineering process) and DIN EN ISO 13488:2001.

Details

May 4, 2005


From 25, April up to 26, April the Eurocat GmbH Institute (Germany) representatives carried out the recertification audit of Neurosoft Company quality management system.

Details

[14:35] April 14, 2005


We received the certificates guaranteeing that Neurosoft Company has a right of drawing CE mark on Neuro-MEP-Micro digital neurophysiological systems.

Details

[17:39] December 23, 2004


Today we received the certificates guaranteeing that Neurosoft Company has a right of drawing CE mark on Neuro-MEP, Neuro-ERG and Neuro-Audio digital neurophysiological systems.

Details


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