Certificate of conformity for medical devices according to SMK-S

Documentation and certificates for the diagnostic complexes "Dianel" for bioresonance NLS diagnosis of the human body, and psychophysiological testing physical health.

 

CERTIFICATE OF CONFORMITY No. ST.RU.0001.М00

This Certificate of Conformity is issued

To the Limited Liability Company "Center of information technologies "NELIAN"

Address: 107023, Moscow, Semenovskiy pereulok str.,

15, building 1, floor 10, room 11

TRN 7720584810  OGRN 5077746809201

Date of issue: 20.02.2021                  Period of validity: 20.02.2024

This certificate certifies that:

Medical Products. Quality Management Systems.

  System requirements for regulatory purposes for work

according to Appendix No. 1 to this certificate

  (the application is an integral part of the certificate)

CORRESPONDS TO THE REQUIREMENTS OF ISO 13485:2016 (GOST R ISO 13485-2017)

 

Appendix № 1

to Certificate of Conformity № ST.RU.0001.М00

Scope of the Quality Management Systems Certification:

 

Activities in the field of health

Activities related to the provision of other personal services

Computer software development, consulting services in this field and other related services

Research and development

 - medical research;

- development, sale of software;

- manufacture, sale, supply, and maintenance of electronic equipment, medical equipment, and medical supplies;

- trade in medical products, including Dietary Supplements;

- trade and procurement activities.

 

 

LICENSE TO USE THE CERTIFICATION SYSTEM CONFORMITY MARK "SMK-STANDARD"

Quality Management System certification authority

INTERNATIONAL CERTIFICATION CENTER Limited Liability Company

 upon a decision to issue the certificate of the quality management systems conformity

 

This Certificate of Conformity is issued

To the Limited Liability Company "Center of information technologies "NELIAN"

Address: 107023, Moscow, Semenovskiy pereulok str.,

building 15, room 422

 

AUTHORIZES

to use the mark of the quality management system conformity for the period of the certificate validity No.ST.RU.0001.М00