Clinical trials of medical devices

This is an integrated service for arranging, conducting and obtaining results of clinical trials of medical devices, including those for in vitro diagnostics.
Selecting a medical facility
Selecting a medical facility for clinical trials of your medical device
Program development
Development and coordination of a clinical trial program with the medical facility
Delivery of the medical device to the medical facility
Delivery of the medical device to the medical facility or arrangement for the investigator's visit to the medical device installation site (if necessary)
Trials monitoring
Obtaining results
Obtaining and adapting the trials results to meet legal requirements to ensure smooth registration of the medical device
Submission to Roszdravnadzor
Submission of completed documents based on the results of clinical trials to Roszdravnadzor
Obtaining a registration certificate
Obtaining a registration certificate
We did not received any negative conclusions, working with new Russian regulatory standing order
You will receive a full clinical trials according all Russian rules foк submit to Roszdravnadzor
You will pay only on when we get positive results
Our quality management system allows for prompt delivery

Customer testimonials

Thank you for your help in obtaining a Registration Certificate for our medical devices Pixel and Avery hearing aids. All registration related work has been performed quickly and professionally. The clinical assessment completed by your staff has saved us time, and the prices for your services are reasonable and reflect the value you deliver.
Maxim V. Murzinov
General Director, Aurika LLC
We would like to express our sincere gratitude for the fruitful cooperation and high quality service in the preparation and conduct of clinical trials for the medical device ENDOCAB endoscope drying and storage cabinet. You have saved us time and helped us achieve the desired outcome.
Denis D. Pozen
General Director, Bandeq-MS LLC
We would like to thank your management and employees for their competence and ability to solve complex, integrated tasks with testing laboratories, the Federal Service for Surveillance in Healthcare and clinical sites. We hope for further mutually beneficial cooperation.
Alexey V. Mazanov
General Director, PTK Belva LLC
The services to support our registration projects have been provided with high quality and professionally. We would like to particularly mention the willingness and ability of your staff to resolve challenging situations with testing laboratories and clinical sites, as well as transparency and timeliness of communications.
Vitaly Khaindrava
Registration Manager for Russia
How to contact us?
Do not be shy |
We appreciate the communication with our customers.
+7 (495) 785-72-85
+7 (495) 785-72-84
Moscow, 109074
2/5/4 Slavyanskaya square, build. 3, office 4057

We are at the metro station Kitai-gorod, in a nearby building with Roszdravnadzor
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