About the Company - МедРег Консалтинг

MedReg Consulting LLC was registered in 2012. All our specialists have university degrees, regularly attend refresher courses and actively participate in a number of professional forums and conferences. The employees have experience in the field of medical devices regulation since 2000.

During the years of successful activity, the company has established business and partnership relations with the best testing centers and medical institutions of the Russian Federation; hundreds of registration certificates, licenses, certificates and declarations of conformity have been obtained.

Medical device registration is a complicated and labor intensive process. The various forms of documentation required for device registration can be confusing. However, our specialists, with their extensive experience and professional knowledge, will easily execute all the necessary documents to form a registration dossier. You don’t need to worry about the registration process. Everything will be done on time and without delay. Upon completion of the registration process, Roszdravnadzor will issue a registration certificate and your company will be able to enter the state register of organizations that have the right to sell medical devices throughout the Russian Federation without unnecessary obstacles, which is important for the safe and quality work of your company.

The list of services offered by our company is quite extensive and includes the following:

The procedure for obtaining an archive copy of the registration documentation for a medical device;
The procedure for obtaining a medical device registration certificate (both standard and accelerated);
Making changes to the registration documentation for a medical device;
Making changes to the registration certificate for a medical device;
Selection of laboratories and analysis of their field of accreditation
Organization of toxicological studies and technical testing of medical devices;
Challenging expert examination results, representing clients’ interests in pre-trial and judicial proceedings;
Preparation of technical and operational documents;
Advising on all issues relating to placing medical devices on the market;
Preparing and collecting documentation, proofreading documentation;
Obtaining permits to import medical devices into the territory of the Russian Federation;
Obtaining quality certificates;
Assistance with the preparation of a declaration of conformity and many other activities.

If you need assistance in obtaining permits for circulation of medical devices in the Russian Federation, we would be delighted to help. Please do not hesitate to contact us for advice, information and a quotation for our services. Our prices for services are individual and depend on many factors including the procedure required and the class of medical product used.

We hope that once you have had the opportunity to benefit from our company’s assistance in registering medical devices, you may wish to contact us again. We would be delighted to be of further assistance with this matter.

COMPANY MANAGEMENT

Expert consultation on all issues related to the medical devices circulation.

Strong points:

The capacity to organize and coordinate work, to identify potential difficulties in advance and to develop strategies for their resolution, to make sound decisions, and to enhance the efficiency and quality of services.

The objective is to facilitate business development.

Expert consultation on all issues related to the medical devices circulation.

Strong points:

The capacity to think outside the box integrating the advantages derived from accumulated experience with original and innovative managerial techniques, and proficiency in one's professional domain.

The objective is to achieve business prosperity.

MEDICAL DEVICE REGISTRATION DEPARTMENT

Igor Lebedev

Education: Higher
Head of Registration Department
Registration Expert

Expert consultation on the adherence to regulatory, administrative and legal requirements.

Strong points:

A critical and objective evaluation of one’s actions, comprehensive knowledge, and ability to consistently and purposefully achieve a defined objective. This entails a clear delineation between primary and secondary objectives, maintaining a sense of purpose and focus amidst the demands of routine tasks, and the capacity to plan and organize one’s work effectively.

The objective is to ensure the quality of the services provided.

Nadezhda Kondrashova

Education: Higher
Expert Consultant on Registration

Expert consultation on matters pertaining to compliance.

Strong points:

The capacity to optimize the positive experiences of others, coupled with a high learning ability, facilitates the establishment of a robust communication system within the organizational structure. This enables the acquisition of reliable information and its effective evaluation.

The objective is to work towards achieving results.

Ludmila Rudyk

Education: Higher
Registration Specialist

Consulting on the preparation of documents for the registration dossier of a medical device

Strong points:

Ability to complete work in a timely and accurate manner, adhere to professional standards and demonstrate responsibility, ability to analyze information, draw conclusions and make informed decisions based on available data, remain calm and productive in stressful situations.

The objective is to quality of services and work towards results.

Oksana Semirikova

Education: Higher
Specialist - Registration Consultant

Consulting on all matters of compliance with regulatory requirements.

Strong points:

Ability to multitask without loss of quality, ability to understand complex problems and find logical and creative solutions, developed ability to achieve high results and complete tasks within the established deadlines, flexibility in working with changes, ability to quickly adapt to new conditions and situations.

The objective is to quality of services and work towards results.