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Uploaded byAndrey Kostychev
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Comprehensive Medical Device Registration and Regulatory Services by KC-PROF

KC-PROF offers expert medical device registration, certification, testing, and regulatory support across Russia and international markets with over 8 years of experience and a dedicated expert team.

Healthcare◦
Related topics:
medical-devices•Medical Equipment Overview•
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your personal expert more than 8 years of successful work in the field of medical device registration KC-PROF INN 5834120456 / OGRN 1 185835002847 info@kc-prof.ru Fregat BC, 4 Admirala Rudneva st., Moscow, 1 17041, Russia Rameev Technopark, 1v Centralnaya st., Penza, 440004, Russia kc-prof.ru/en +7 (950) 231-01-03 +7 (950) 231-01-03
8+ years of industry experience successful projects 800+ 11years average experience of our experts registered devices 300+ 16 experts in the team PhDs in staff 3 Russian regions 36 23 customer countries customer satisfaction 97%+ MD’s under AR responsibility 60+ Numbers
2018 2019 Expert Team The team consists of 6 specialists, the number of clients and projects is rapidly increasing History 2020 Biomedical Cluster The company becomes a member of the Biomedical Engineering Cluster «Biomed» Company Establishment The first registration projects have been launched
2022 2024 Reaching New Heights A company’s branch has been established in the Republic of Armenia to offer more convenient services to our international customers 2025 - 2026 Keep Moving Forward A partnership agreement was signed with the Chinese-Russian Center for Standardization and Technology Transfer in Healthcare (Beijing, China). Continuing to improve and develop, creating new ways to help successfully complete our clients' projects in the shortest possible time Dynamic Growth The number of registration experts reaches 12 people. A group of registration of medical devices for in vitro diagnostics has been assembled. Implementing of the business process automation systems
KC-PROF Services •Registration of medical devices according to national regulations •Medical device registration in accordance with the EAEU regulations •Accelerated registration procedures for medical devices in Russia •Authorized Representative of the Foreign Manufacturer •Amendments to all types of medical device registration documents •All types of medical device testing: technical, toxicological, biocompatibility, clinical, EMC, testing for pattern approval of measuring instruments, and clinical laboratory testing •Development of any documentation required for medical device •Other ways of certification and declaration •Preparation for and support during inspections (audits) •Post-market clinical follow-up •Licensing of medical equipment maintenance •Assistance with localization of production in the territory of the Russian Federation •QMS development and implementation •Support in handling Roszdravnadzor letters and requests •Individual projects
Clients DONGBANG MEDICAL VALGEN MEDTECH ® 华锡尔医疗
Our clients include major medical device manufacturers and distributors from 23 countries. We currently serve as the Authorized Representative for 62 medical devices from foreign manufacturers Client Geography Russia China India USA Japan Brazil Turkey South Korea Spain Austria Germany Italy Croatia Netherlands
“Thank you for your cooperation and support throughout the registration process for our medical devices, as well as for your timeliness, responsiveness, and ability to find effective non-standard solution“ Alexandr Koster Regulatory Affairs Manager Amann Girrbach AG “We would like to highlight the extensive experience and expertise of the company’s employees. They supported us in resolving numerous issues and made every effort to expedite the registration process“ Liu Qing CEO B. J. ZH. F. Panther Medical Equipment Co., Ltd. “KC-PROF team demonstrated a structured and professional approach to managing the registration. We consider KC-PROF a reliable partner and appreciate their expertise in supporting complex regulatory projects“ Steven Fan Director Bonanga Technology Co., Ltd “We would like to thank the company’s management and experts for their competence and ability to solve complex and challenging tasks, including the organization of testing in accredited laboratories and clinical centers“ Alla Stratau Director LLC Esperto “We would like to thank KC-PROF team for their outstanding assistance in registering our medical devices. The registration have been obtained successfully, and we owe this achievement to your commitment“ Song Liang Legal Representative Insignt Lifetech Co., LTD “Our company is grateful for cooperation and support of processes related to the development of documents and registration of medical devices manufactured by our company“ Joseph Fan President ACRO BIOTECH Inc. “We would like to express our sincere gratitude for your comprehensive support and professional assistance in preparing for the Roszdravnadzor inspection of our medical device production site“ Amanda Yan CTO LifeTech Scientific Corporation “Thank you for your professionalism, promptness, diligence, and for fulfilling all undertaken obligations on time. We look forward to further fruitful cooperation with you“ Marina Semenova Deputy Director for Quality LLC ARKRAY Testimonials
A major Russian manufacturer of in vitro diagnostic devices contacted us in 2018 after several registration denials. We completely revised the documentation, conducted laboratory testing, then registered the product. To date, we have registered 19 products for them. All regulatory tasks, from documentation development to post-registration monitoring, have been delegated to us A Chinese company, one of the world's leading manufacturers of medical devices, localized the production of patient monitors and anesthesia machines in Russia. We have developed and implemented a quality management system (QMS), followed by a successful on-site audit of the production site. Products manufactured at the Russian site have been successfully registered A leading Chinese manufacturing company of surgical medical devices, including staplers, trocars, and ultrasonic surgical systems, was seeking a partner to handle all matters related to the registration and distribution of their products in the Russian Federation. Since 2019, we have been acting as the AR for all of their products, and to date, we have registered 1 1 products A Russian distributor of orthopedic medical devices set a goal of quickly obtaining registration for three medical devices. We proposed the most efficient approach—the simplified registration path in accordance with Resolution No. 552 of April 1, 2022. Subsequently, the products underwent the confirmation procedure and were permanently registered 09 Case Studies
KC-PROF Additionally, to a personal technical registration expert, the project is handled by a personal manager Personal Expert Affordable Prices Prices are 15-20% lower than the market average. Additional discounts are provided for the simultaneous launch of several projects Full Transparency We provide detailed information about the progress of work and all potential costs and risks Following Deadlines We carry out our work within the time frame established by the agreements Comfortable Approach to Project Implementation You can choose either to complete the entire project or to implement part of it Our specialists provide free consultations on the issues you are interested in Free Consultations A robust system for training and professional development for experts, a large database of completed projects High-Quality Staff We begin work on the project before payment. Offering the most profitable project implementation strategy from the moment you contact us Initiate Work Immediately A convenient payment system is payment for the result at most stages Post-Payment Approach We proceed to the next stage only after agreeing on the results of the previous one Confirmation Why Choose Us Coordination of Work Progress We report on the progress of work in accordance with the stages established by the contract
We guarantee complete confidentiality, non-disclosure of data, and legal protection of the client's interests. Signing NDA if necessary Confidentiality We develop the most appropriate strategy for solving a specific task, taking into account the further stages of the project and the long-term goals of the client Thorough Analysis and Attention to Detail The developed documents can be easily verified in official state registers and databases 100% Verified Documents The expert revises the documents until they are fully approved by the client Revising Until Full Approval If your product can be registered as a medical device, we will get it registered — no matter how complex the process may be Results-Oriented Approach We specialize exclusively in services related to the circulation of medical devices. Therefore, 8 years of work without a single legal dispute confirm the reliability of our company Reliability Full Range of Services From document development and registration to post-sales monitoring and AR services Discount and loyalty programs are available for regular customers, creating more favorable terms of cooperation and reducing project costs Discount Issue Why Choose Us C-PROF
Sergey Evdokimov CEO, Founder 14 years of work experience. Managing a company and the Medical Device Manufacturing Localization Group. Extensive experience in bringing medical devices to the EU market Andrey Kostychev CTO, Founder PhD in Biology. 18 years of work experience. Head of the Medical Device Development and Testing Group. Former head of an accredited testing laboratory for many years Tatiana Egorkina Head of the Medical Device Registration and Certification Department 1 1 years of work experience. Registration of products of varying complexity. Management and supervision of medical device registration projects Andrey Kuznetsov Head of the QMS Development and Implementation, Audit and Licensing Department PhD in Biology. 20 years of work experience. Preparation of manufacturing sites for on-site audits from the initial stage. Implementation of a Quality Management System 12 Team
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get FREE consultation CTO, cofounder KC-PROF +7 (950) 231-01-03 INN 5834120456 / OGRN 1 185835002847 kostychev@kc-prof.ru Fregat BC, 4 Admirala Rudneva st., Moscow, 1 17041, Russia Rameev Technopark, 1v Centralnaya st., Penza, 440004, Russia kc-prof.ru/en +7 (950) 231-01-03