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.

Steps:

Selecting a medical facility for clinical trials of your medical device

Selecting a medical facility

Program development

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)

Obtaining results

Submission to Roszdravnadzor

Submission of completed documents based on the results of clinical trials to Roszdravnadzor

Obtaining a registration certificate

Monitoring

Trials monitoring

Development and coordination of a clinical trial program with the medical facility

Obtaining and adapting the trials results to meet legal requirements to ensure smooth registration of the medical device

Obtaining a registration certificate

WORKING WITH US,
YOU WILL GET

GUARANTEES

We did not received any negative conclusions, working with new Russian regulatory standing order

COMFORT

You will receive a full clinical trials according all Russian rules foк submit to Roszdravnadzor

INTEGRITY

You will pay only on when we get positive results

SPEED

Our quality management system allows for prompt delivery

We are trusted

and more than 20 clients

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 http://www.aurica.ru

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 http://www.bandeq.ru

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 http://www.belva.ru

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 http://dentsplycis.com

Submit request

Contacts

+7 (495) 785-72-85
+7 (495) 785-72-84

info@medrelic.ru
Moscow, 109074
2/5/4 Slavyanskaya square, build. 3,
office 4057