Alfa-Med LLC

Manufacture Sensitiv imago machines

Company is having own research and manufacturing facilities in Moscow, Omsk, Novosibirsk and have representative offices in Europe. It also cooperates with the variety of the research and medical institutions. That allows to provide the full cycle of the experiments and tests with the new equipment.

Company's achievements that correspond the high quality standards are approved with lots of Certificates – including ISO quality Certificates. We use the five-step process of the quality control (5SI)  we are providing the test for each party and provide the inspection of each devices party to approve correspondence to the technical requirements. Qualified technologists provide the security of the manufacturing processes accurately and in time.

Alfa-Med LLC is constantly working on the update of the diagnostic devices range, improvement of their quality and new technologies introduction. Narrow specialization of the equipment inspires manufacturing engineers to widen its functionality on account of heir own inventions. That's why separate components of the complex have no analogs in Russia.

 

 

ISO - International Organization for Standardization
ISO - International Organization for Standardization

Certificates

Identification certificate of the European Union for 3 models manufactured by medical Class 1. Testing laboratories, test performed in UK according to the EU standards

European Certificate corresponding Class 2- medical equipment. The certificate was obtained for 4 models

Certificate for the line of equipment of the Ministry of Emergency Situations of the Russian Federation

Hygienic Certificate of the manufacturer 1

Certificate of Conformity of the Russian Federation

Certificate of production according to ISO 9001: 2008 Rus standards and the latest directive of 2014

Certificate for manufacturig, development, design, scientific activity according to the ISO 9001:2008, revision 2014

Certificate of quality management 13485 issued by the European Union for the production and design of medical devices

Certificate of the management system for the production of medical equipment in accordance to EU Standard 13485

Diploma to the Gold Medal of the European Union in the field of development of innovative technologies

Class 1 Declaration

The Certificate of SENSITY IMAGO belonging to the division of Alfa-Med Holding in the part of electronic engineering, technology and programming

Certificate of SENSITIV IMAGO belonging to Alfa-Med Holding in terms of medical equipment and technology

The certificate of belonging of IMAGO TECHNOLOGY to the subdivision of the Alpha-Med Holding in terms of electronic engineering, technology and programming

The certificate of belonging of LifeStream to the subdivision of the Holding Alpha-Med in terms of medical equipment, technology and programming

Certificate confirming the performing of the audit for the right to manufacture medical equipment in accordance to the 2014 directives

Certificate confirming the audit in 2014. Audit for the right to develop medical equipment under the 2014 directives

Registration in Ukraine Certificate

EU Medical device registration Certificate

Latvian Medical Certificate

Great Britain Registration

TUV 2016 Tests

Laboratory Tests in EU 2016 LEI-C

Certification FDA