ISO 13485 : 2003 Certification
· On 21.02.2008 TUV Rheinland MEEI certifying body issued to the Institute of Practical Psychophysics the following documents:
1. Certificate No. М28 2892059 from 21. 02. 2008 confirming compliance of quality management system with requirements of ISO 13485:2003 standard. Field of quality management system application is design, development, manufacturing, sales and servicing of hardware-software bio-resonance diagnostics systems. The certificate is valid until 20. 02. 2013.
2. Certificate No. М26 2892077 01 from 21. 02. 2008 confirming "Metatron” hardware-software bio-resonance diagnostics systems (models: Metatron - 4015, Metatron - 4017, Metatron - 4019, Metatron - 4021, Metatron - 4025, Metatron - TorDi) manufacturing compliance with requirements of EU Directive 93 / 42 / EEC; Annex V, Article 3. The certificate allows using of CE labeling. The certificate is valid until 20.02.2013.
On 28-29 of February, 2008, the Institute of Practical Psychophysics successfully passed review audit of quality management system (QMS) for compliance with requirements of International Standard ISO 9001 : 2000 in field of design, development, production, sales and servicing of bio-resonance diagnostics systems in Bureau Veritas Certification (BVQI) certification body with accreditation in UKAS (UK), ANAB (USA), DAR (Germany).
ISO 9001 : 2000 Certification
March, 2007
In February the Institute of Practical Psychophysics was certified according to ISO 9001 international standards as the developing, designing, producing, selling and servicing organization of bio-resonance diagnostic systems. The certification was carried out by BUREAU VERITAS Certification (BVQI) with accreditation in 31 country including Japan, Southeast Asia and Canada, by UKAS (UK), ANAB (USA) and DAR (GERMANY).
Certification audit of management quality system (MQS) confirming ISO 9001: 2000 International Standard was carried out on 21st - 22nd of February, 2007 according to audit program from 07th of February, 2007. Representatives of company's top and middle management and senior auditor of Bureau Veritas Certification participated in opening and final meetings.
Sphere of certification: "Design, development, production, sales and servicing of hardware-software bio-resonance diagnostics systems".
Audit criteria were requirements of ISO 9001: 2000 International Standard and own requirements of the company, stipulated by MQS.
Certificate Number: 210609
Date: 15 March 2007
WORLDWIDE RECOGNITION OF BVQI
31 ACCREDITATION ACCORDING TO ISO 9001: 2000
- Australia
- Austria
- Argentina
- Belgium
- Brazil
- Great Britain
- Venezuela
- Germany
- Denmark
- Spain
- Italy
- Canada
- China (Hong Kong)
- Columbia
- Korea
- Mexico
- New Zealand
- Netherlands
- Pakistan
- Portugal
- Poland
- Singapore
- USA
- Taiwan
- France
- Czechia
- Chili
- Switzerland
- Sweden
- Japan
Director of the IPP V. I. Nesterova
Trademark and Registration
March, 2007
Professor Vladimir Nesterov received Metatron trademark registration certificate for Germany and Europe and European registration certificates for "NutriSoft", "Metapathia GR Practical", "Metapathia GR Professional", "Metapathia GR Hunter" and "Metapathia TorDi" software.
Federal Department of Healthcare and Social Development Supervision issued to the Institute of Practical Psychophysics a registration certificate for medical technology: "Method of screening diagnostics using hardware-software system Metatron"
FEDERAL DEPARTMENT OF HEALTHCARE AND SOCIAL DEVELOPMENT SUPERVISION
REGISTRATION CERTIFICATE
No. ФС-2006/382 from 29th of December, 2006
valid until 29th of August, 2010
Name of medical technology: Method of screening diagnostics using hardware-software system "Metatron"
Annotation: Method of orientation screening diagnostics of functional disturbances in human body is carried out using hardware-software system "Metatron" and lies in location of possible area of pathological process and its intensity (reliability 79.7% ). Method of screening diagnostics is based on noninvasive use of electromagnetic signals (1,8-8,2 Hz) and biological feedback (BF) among operator, patient and hardware unit. As a result an outline of BF is formed, initiating trigger receives a reaction of patient's brain waves to an irritant and sends digital signal back to hardware unit. This technology allows saving time of research, including mass prophylactic examination, helps to determine personal program of precise diagnostics necessary for specification and verification of prior diagnosis, helps to estimate a dynamics of functional changes in human body.
Indication, contra-indication, material and technical equipment are shown in Attachment*.
Developers/declarants:
- Non-governmental Non-commercial Educational Institution "Moscow Institute of medical and social rehabilitology" (2nd Parkovaya str. , 24/28, Moscow, 105037)
- The Institute of Practical Psychophysics LLC (Bethovena str. , 33, Omsk, 644082)
Application: Treatment and prophylactic institutions (municipal and regional hospitals, polyclinic, medical department, sanatoriums and private clinics) equipped with hardware-software system "Metatron" and having all necessary licenses for medical activity.
Medical technology is intended to be used by: Therapists, general practitioners (family doctors), functional diagnostics doctors.
Director R. U. Khabriev
*Registration certificate is not valid without Attachment