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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.

The formation of the quality management system of the company started in 2001 year. That year Neurosoft got the certificates of conformance to GOST R ISO 9002-96 standard requirements.

In 2004 the quality management system (except the engineering process) was certified according to International standards DIN EN ISO 9001:2000 and DIN EN ISO 13488:2001 requirements.

The certification of all the quality management system of the company (without any exceptions) in conformance to the International standards DIN EN ISO 9001:2000 and DIN EN ISO 13485:2003 requirements was the natural continuation of its formation and consolidation.

It should be mentioned, that the standard DIN EN ISO 13485:2003 replaced DIN EN ISO 13485:2001 and DIN EN ISO 13488:2001 standards and determines the requirements to the quality management system of the companies involved into the manufacturing, installation and servicing of the medical systems. As in 2004, in this year, the certification was performed by one of the leading International organizations Eurocat (Germany).

 

What is it for?

The presence of the certified quality management system on the enterprise plays an important role in the guaranteeing of the stable manufacture of the same quality and safe production with the high service properties, and it also provides the customer with the assurance in the company's capabilities and image.

That means that the devices, produced to the controlling organization for the registration and the certification, and the products presented on the exhibition are absolutely identical to the ones (just as reliable, accurate and safe) delivered by the company to the customers.

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

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

[11:32] November 11, 2004


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 neurophysiological systems.

Details


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