Monitoring program
We develop a post-clinical monitoring program taking into account the characteristics of the medical device and legal requirements.
Why choose us
Constant monitoringWe monitor legislative changes and assess their impact on registered medical products.
Optimal solutionsWe quickly analyze emerging problems, propose a course of action and support the necessary procedures.
Expert supportWe take care of interaction with government agencies and help fulfill post-registration requirements.
Product support after registration
Obtaining a registration certificate is not the completion of work, but the beginning of a new stage in the circulation of a medical product on the market. After registration, the manufacturer is obliged to comply with the requirements of the law, maintain the relevance of the registration dossier, make timely changes to the documentation, conduct post-clinical monitoring of the safety and effectiveness of the medical device, as well as comply with other requirements of Roszdravnadzor.
We provide comprehensive post-registration support for medical devices, helping manufacturers timely comply with all regulatory requirements and ensure product compliance with current legislation throughout the entire period of application.
What is included in the service
We provide a full range of post-registration support services, including:
- consultations on the circulation of medical devices;
- support of procedures for making changes to the registration dossier (VIRD);
- updating of technical and operational documentation;
- analysis of changes in legislation and assessment of their impact on registered medical devices;
- preparation of documents upon requests Roszdravnadzor;
- support of interaction with government authorities;
- consulting on labeling, packaging and operational documentation;
- support when changing information about the manufacturer or production site;
- expert support on compliance with regulatory requirements;
- organization and support of post-clinical monitoring of medical devices.
Post-clinical monitoring
Post-clinical monitoring is an important part of the post-registration support system for medical devices and is aimed at constantly assessing the safety and effectiveness of the product during its circulation on the market.
Data collection and analysis
We help organize the collection and analysis of information about the safety and effectiveness of a medical device during the treatment process.
Result evaluation
We evaluate the data obtained and help determine whether additional regulatory action is required.
Monitoring reporting
We prepare reports on the results of post-clinical monitoring in a format suitable for regulatory support.
Requirements consultation
We advise on compliance with legal requirements and keeping documentation up to date.
Interaction with Roszdravnadzor
We support communication with Roszdravnadzor when queries arise or the need to provide materials.
Our approach
We conduct post-registration support as a sequential process: from monitoring requirements to updating documentation, monitoring and consulting support.
Result
Comprehensive post-registration support allows you to keep the registration dossier up to date, timely comply with legal requirements, organize post-clinical monitoring and ensure unhindered circulation of medical devices in the Russian Federation.
Our specialists remain a reliable partner of the manufacturer throughout the entire life cycle of the medical device, providing expert support in resolving any regulatory issues.
