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

We certified Neuron-Spectrum-5, Neuron-Spectrum-5/S, Neuron-Spectrum-4/EPM, Neuron-Spectrum-4/EPM/S, Neuro-MEP, Neuro-ERG, Neuro-MEP-5 и Neuro-MEP-5/2 for compliance to IIb class requirements according to Annex II of Council Directive 93/42/EEC of 14 June 1993 “Concerning Medical Devices”.

Annex I “ESSENTIAL REQUIREMENTS” of this directive states that “The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.”.

Medical devices are divided into safety classes depending on risk hazard. Each medical item can be related to only one class. The degree of potential risk rises with the class number increase (I, IIa, IIb and III). Devices with moderate degree of individual risk and (or) low degree of risk for social health care and environment fall within Class II. It in turn is divided into IIa and IIb classes with moderate and high risk degree correspondingly.

According to classification the devices fall within IIb class “if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient..

Thus, this certificate for compliance to IIb class requirements is an obligatory condition for device use in operating rooms and intensive care units on the territory of European Community.

For equipment manufacturer it results in considerably tightened quality control of development processes.

Recent audit of QMS revealed that the development processes of our company correspond to these high standards and now Neurosoft equipment can be used in operating rooms and special care wards of medical establishments of European Community.

Publication date: March 9, 2011

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[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.

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[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.

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[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.

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[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.

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[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.

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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.

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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.

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[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.

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[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.

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[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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