REGISTRATION OF MEDICAL DEVICES
We provide a full range of services for the registration of medical devices of domestic and foreign manufacture.
About Company
Panda Med LLC founded in 2012
For over 10 years, we have been helping our clients implement technical and commercial solutions to enter the medical device market.
Hundreds of issued registration certificates, in-depth technical expertise, and an individual approach to each customer allow us to reduce time of process certification.
For over 10 years, we have been helping our clients implement technical and commercial solutions to enter the medical device market.
Hundreds of issued registration certificates, in-depth technical expertise, and an individual approach to each customer allow us to reduce time of process certification.
SERVICES
Registration of medical devices (MD), amendments to registration documents (VIRD), testing, document development, localization, sales.
- Potential risk classes 1, 2a, 2b, and 3
- sterile and non-sterile
- domestic and foreign production
- post-registration support
- add amendments to the registration dossier
- pre and support of all types of testing
on the following issues:
- registration
- import of samples
- testing
- disposal
- control and monitoring
- main functions of the authorized representative of the manufacturer
- localization of production
- licensing of activities related to the technical maintenance of medical devices
Developing recommendations for:
- increasing sales potential for medical devices
- reducing production costs
- expanding the scope of application of medical devices
- R&D: competitive research, identifying global trends, identifying promising niches, developing product market results, assessing technology prospects, optimizing processes, ensuring the security of sustainable developments and managing patent applications, verifying the quality and reliability of solutions.
- Sales funnel development, CJM, conversion rate increase.
- Development: complex international, developing process thinking, monitoring decision maker loyalty for KAM, team building with clients for long-term partnerships.
- Assistance in localizing medical device production in Russia:
- Panda Med offers services to assist with localizing medical device production in Russia, with the goal of creating favorable conditions for increasing sales. These services include:
- searching for partners for production in Russia;
- assistance in organizing localized production;
- registration of localized medical devices (manufactured in Russia);
- inclusion of products in the register of Russian manufacturers;
- management of a sales team to sell localized products.
- Main technical documentation (TU/Technical File, Risk Management File (RMF), Design File with Usability (DSU));
- Operational documentation (Operating Manual, Passport, Instructions for Use, etc.);
- Supplementary technical documentation (Life Cycle File (LCF), Validation Report);
- Test documentation (Test Plan and Scope, Test Protocol Designs and Templates, Reporting Documents, Applicable Test Programs: Factory, Qualification, Standard, and Periodic);
- Quality Management System (QMS) documentation
- Consulting on the scope and types of necessary testing
- Search for laboratories and organization of all types of testing (toxicological, technical, clinical, etc.)
- Development of testing documentation (test plan and scope, test protocol designs and templates, reporting documents, applicable test programs: factory, qualification, standard, and periodic)
- Preparation, organization, and monitoring of testing processes (toxicological, technical, clinical, etc.)
- Exhibitions and conferences participation assists of foreign manufacturers:
- promoting medical devices on the Russian market.
- researching and analyzing events aimed at promoting medical products: exhibitions, forums, conferences
- developing or adapting presentation materials for the Russian market.
- determining the size and location, reserving and purchasing exhibition space.
- designing an exhibition stand in accordance with the manufacturer's requirements.
- arranging the manufacturer's participation in the event: transportation, hotel, accommodation, and interpreter services.
- Support for medical device maintenance activities
- Recommendations and assistance in developing additional technical solutions
- Search and engagement of relevant specialists upon request (in the field of quality management systems, enterprise technical audit, etc.)
- Development of graphic documents (drawings, sketches, diagrams, 3D images, etc.)
- Organization of documentation translation, including notarized translation
- Other services upon request
328
Yes, this is how many medical device we already certified for our clients, and this number is growing every day. Please see below some of the registered products.
Why customers choose Panda Med
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Panda Med LLC, INN 7723832860
