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Application for medical device development service
Application for Medical Device QMS Service
Application for medical device registration service
Application for registration of medicines
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Application for technical and medical translation
RZN.Expert is a company specializing in the development, implementation and maintenance of quality management systems, regulatory framework for medical devices in the Russian Federation and the Eurasian Economic Union (EAEU). During our work, we have established ourselves as a professional and reliable partner.
About us
In the medical device registration market
Number of successful projects
Geography of our customers in the Russian Federation
4 years
Geography of foreign partners
>200
8 regions
8 countries
RZN-Expert is a team of experienced specialists who have been solving issues related to the circulation of medical devices on the market since 2021.
Video presentation of PZN.EXPERT
With whom we work
We work with:
Foreign and domestic manufacturers of medical devices of all risk classes;
Distributors and importers of medical devices;
Medical institutions;
Medical institutions;
Research institutesand offer a full range of services for bringing medical devices to the market - from development to implementation of a quality management system according to ISO 13485, including a full range of services for registering medical devices with Roszdravnadzor.
Our goal is to become your reliable partner on the path to success in the field of production and sale of medical devices
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Contact us
We will be happy to help you understand the intricacies of the legislation related to the handling of medical products!
RZN-Expert specialists
(Click on the image to see more details about the employee)
Tandelov Artemi-Tatusch Tymyrazovich
Director of Quality and Management
Specialist in the development of medical devices for in vitro diagnostics
Specialist in the development of medical devices made of polymeric materials
Specialist in the registration of IVD medical devices
Specialist in QMS implementation in production
Specialist in risk management
Education:
Bachelor’s Degree: Chemical Engineer, Chemist – M. V. Lomonosov Institute of Fine Chemical Technologies.
Master’s Degree: Bauman Moscow State Technical University.
PhD Studies: N. M. Emanuel Institute of Biochemical Physics, Russian Academy of Sciences.
Professional retraining
from the Federal State Budgetary Institution "VNIIMT" of Roszdravnadzor (Medical Device Registration Manager within the EAEU framework).
Advanced training in ISO 13495 and ISO 14971.
Over 5 years of experience in the manufacturing and regulation of medical devices and pharmaceuticals.
Specialist in the development of medical devices for in vitro diagnostics
Specialist in the development of medical devices made of polymeric materials
Specialist in the registration of IVD medical devices
Specialist in QMS implementation in production
Specialist in risk management
Education:
Bachelor’s Degree: Chemical Engineer, Chemist – M. V. Lomonosov Institute of Fine Chemical Technologies.
Master’s Degree: Bauman Moscow State Technical University.
PhD Studies: N. M. Emanuel Institute of Biochemical Physics, Russian Academy of Sciences.
Professional retraining
from the Federal State Budgetary Institution "VNIIMT" of Roszdravnadzor (Medical Device Registration Manager within the EAEU framework).
Advanced training in ISO 13495 and ISO 14971.
Over 5 years of experience in the manufacturing and regulation of medical devices and pharmaceuticals.
Director of Operational Processes and Risk Management.
Education:
Bachelor’s Degree: Biologist – Kalmyk State University, major in Biology.
Advanced training in ISO 13495 and ISO 14971.
Over 4 years of experience in the development and regulation of medical devices.
Education:
Bachelor’s Degree: Biologist – Kalmyk State University, major in Biology.
Advanced training in ISO 13495 and ISO 14971.
Over 4 years of experience in the development and regulation of medical devices.
Mikhailov Nikolay Alexandrovich
Head of the Beijing Office
Education:
Bachelor’s Degree: Moscow Aviation Institute
Master’s Degree: Moscow Aviation Institute
Master’s Degree in China: Beijing Institute of Technology
PhD Studies: Institute for Problems of Mechanical Engineering, Russian Academy of Sciences
Advanced training in ISO 13495 and ISO 14971.
Over 5 years of experience in the regulation of medical devices from foreign manufacturers.
Education:
Bachelor’s Degree: Moscow Aviation Institute
Master’s Degree: Moscow Aviation Institute
Master’s Degree in China: Beijing Institute of Technology
PhD Studies: Institute for Problems of Mechanical Engineering, Russian Academy of Sciences
Advanced training in ISO 13495 and ISO 14971.
Over 5 years of experience in the regulation of medical devices from foreign manufacturers.
Aksenov Yegor Pavlovich
Key Account Manager.
Education:
Bachelor’s Degree: St. Petersburg State University, Law with an in-depth study of Chinese language and PRC law.
Over 3 years of experience in international sales consulting.
Education:
Bachelor’s Degree: St. Petersburg State University, Law with an in-depth study of Chinese language and PRC law.
Over 3 years of experience in international sales consulting.
Shelkovskaya Sofia Igorevna
Clinical Research Specialist for Medical Devices and Pharmaceuticals.
Education:
Specialist Degree: Endocrinologist – I. M. Sechenov First Moscow State Medical University.
Residency: Endocrinologist – I. M. Sechenov First Moscow State Medical University.
Education:
Specialist Degree: Endocrinologist – I. M. Sechenov First Moscow State Medical University.
Residency: Endocrinologist – I. M. Sechenov First Moscow State Medical University.
Terekhin Dmitry Sergeyevich
Medical Device Registration Specialist.
Education:
Bachelor’s Degree: Chemical Engineer – M. V. Lomonosov Institute of Fine Chemical Technologies.
Master’s Degree: Chemical Engineer – M. V. Lomonosov Institute of Fine Chemical Technologies.
Education:
Bachelor’s Degree: Chemical Engineer – M. V. Lomonosov Institute of Fine Chemical Technologies.
Master’s Degree: Chemical Engineer – M. V. Lomonosov Institute of Fine Chemical Technologies.
Nechaev Ilya Igorevich
Nechaev Ilya Igorevich
Medical Device Registration Specialist.
Terekhin Dmitry Sergeyevich
Clinical Research Specialist for Medical Devices and Pharmaceuticals.
Shelkovskaya Sofia Igorevna
Manager of key clients.
Aksenov Egor
Pavlovich
Pavlovich
Head of the Beijing office.
Mihailov Nikolay Alexandrovich
Director of Operations Processes and Management.
Tandelov Artemi-Tatusch Tymyrazovich
Director of Quality and Management of the Organization.
Nechaev Ilya Igorevich
Medical Device Registration Specialist.
Terekhin Dmitry Sergeyevich
Clinical Research Specialist for Medical Devices and Pharmaceuticals.
Shelkovskaya Sofia Igorevna
Manager of key clients.
Aksenov Egor
Pavlovich
Pavlovich
Head of the Beijing office.
Mihailov Nikolay
Alexandrovich
Alexandrovich
Director of Operations Processes and Management.
Tandelov Artemi-Tatusch Tymyrazovich
Director of Quality and Management of the Organization.
We assist both international and domestic manufacturers in bringing their products to market and making your business successful!
Reviews about us
m. Kropotkinskaya
Moscow, Voekhonka Street, 15
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