WITH US, YOU WILL GET FULL AND QUALIFIED ASSISTANCE IN THE FIELD OF MEDICAL DEVICES REGULATION

FULL LIST OF OUR SERVICES

PROFESSIONALISM - RESPONSIBILITY - RESULT

Medical device registration on the territory of the Russian Federation

State registration of medical devices for Russian and foreign manufacturers.

Medical device registration in the European Union (EU)

Carrying out the registration process of medical devices on the territory of the European Union.

Amendment procedure (VIRD & VIRU)

Registered dossier amendment (VIRD procedure).
Registration certificate amendment (VIRU procedure).

Technical documentation

Development and optimization of technical and operational documentation.

Medical device registration within the EAEU

State registration of medical devices in the countries of the Eurasian Economic Union: Russian Federation, Kazakhstan, Belarus, Kyrgyzstan, Armenia.

Quality management system certification (QMS)

Development and implementation of the quality management system for medical devices ISO 13485 and ISO 9001 with the guarantee of successful certification with international accreditation.

Medical device testing

Organization and support of toxicological studies, technical and clinical tests, electromagnetic compatibility (EMC) tests, medical devices type approval tests.

Distributor / Authorized representative in Russia

Searching for a Distributor / Authorized representative of the manufacturer in the Russian Federation. Service for foreign manufacturers.

ADDITIONAL SERVICES

Medical device consultation service.
Preparation of documents for obtaining a duplicate of the registration certificate.
Preparation of documents for replacing the registration certificate.
Service for receiving explanatory letters from Roszdravnadzor.

Audit of documentation.
Preparation of documents for obtaining permission to import samples for registration.
Support for obtaining certificates and declarations of conformity.
Translation of documents and notarization.