Alfa-Med

5SI Quality control

Alfa-Med quality control process represents the complex of interrelated actions that guaranty the safety and effectiveness of each device manufactured by Alfa-Med. We want to make it perfectly clear that Sensitiv is unmatched in terms of information and security of biofeedback research.

Quality of the product manufactured start at the design stage. This stage is interrelated with the lowering of corrections quantity that will appear in the product at the stage of new versions development.

In result when comparing the value of the real product and the expectations of the customers – the deviations are miniscule. At the manufacturing stage the Statistic Process Control – SPC – is the most important instrument which detects the sources of the process variability and blocks the appearance of the new ones.

Devices using the Alfa-Med technology are considerably superior to all the available bio-resonance diagnostic and health-related techniques by any definition. For the time being, the rival companies' devices are only able to imitate a small subset of functions inherent in our equipment.

about the method

Orientation on consumer

Main goal of Alfa-Med is to take into consideration the factor of customer's satisfaction and supplying customer with the competitive and quality goods.

The value of the product n this case is determined by the grade of its need for the customer and the quality level.

Highly qualified staff

Significant part in the Alfa-Med activity is given to the personnel (staff) training in any department of the company

Post-sales service / Operating quality

Presence of the post-sales service is the decisive factor for the client when making his mind about the device purchase. Alfa-Med specialists are constantly tracking he customers opinion about the device quality at every stage of its operation

Cooperation with the well-tried suppliers

Many years experience in medical devices manufacturing allowed to develop the own system of the parts quality evaluation. That allowed to lower the number of the parts suppliers thus increasing the quality of the goods manufactured

Certification

The company's achievements that meet high quality standards are confirmed by numerous certificates, including ISO (International Organization for Standardization) quality certificates.

Alfa-Med technologies have been recognized all over the world: in Europe and Asia, America and Russia.

  • 1
    Certificate_EC part A Annex III directive 2014/30/EU 2018_SensitivE Audit model 550. Monitoring non-vital physiological parameters
  • 2
    Certificate Registration FDA 2018 Sensitive audit 555 is registered and has listed the following medical device with the US
  • 3
    Certificate Registration FDA 2016-2021 Sensitiv imago 535, 135
  • 4
    EU 2016 certificate CE 530, 130.
  • 5
    Certificate of the Russian Federation Customs Union 2015-2020 Express Test System Sensitiv imago 7 models.
  • 6
    RF Certificate 2009 for 9 Sensitiv Imago Models
  • 7
    European Certificate corresponding Class 2- medical equipment. The certificate was obtained for 4 models
  • 8
    Identification certificate of the UK for 3 models manufactured by medical Class 1. Testing laboratories, test performed in UK according to the EU standards
  • 9
    Device Certification in Ukraine
  • 10
    Certificate for Latvia
  • 11
    Declaration
  • 12
    International Certificate of production according to ISO 9001: 2008 Rus standards and the latest directive of 2014
  • 13
    European International Certificate for manufacturig, development, design, scientific activity according to the ISO 9001:2008, revision 2014
  • 14
    Certificate of quality management 13485 issued by the European Union for the production and design of medical devices
  • 15
    Certificate of the management system for the production of medical equipment in accordance to EU Standard 13485
  • 16
    Registering Lifestream software in the United States
  • 17
    Hygienic Certificate of the manufacturer Russia
  • 18
    Certificate for the line of equipment of the Ministry of Emergency Situations of the Russian Federation
  • 19
    Certificate confirming the performing of the audit for the right to manufacture medical equipment in accordance to the 2014 directives
  • 20
    Certificate confirming the audit for the right to develop medical equipment under the 2014 directives
  • 21
    Testing devices in the German laboratory TUV
  • 22
    Laboratory Tests in EU 2016 LEI
  • 23
    EMC tests on medical parameters 60601_1_2
  • 24
    IEC 60601-1:2005 Medical electrical equipment
  • 25
    Registration of a factory for the USA
  • 26
    Trademark Registration SENSITIV I M A G O priority from 2005
  • 27
    Registration of the brand SENSITIV IMAGO priority from 2011
  • 28
    Trademark Registration LifeStream priority from 2012
  • 29
    Brand registration IMAGO TECHNOLOGY priority from 2012
  • 30
    Registration of the brand SensitivE imaGO priority from 2017
  • 31
    Registration of the brand SensitivEGO priority from 2016
  • 32
    Registration of the brand SensitivE Audit priority from 2018
  • 33
    Registration of the brand ALFA-MED priority from 2019
  • 34
    Diploma to the Gold Medal of the European Union in the field of development of innovative technologies