The Aliquot Scientific and Medical Laboratory is included in the list of medical organizations conducting clinical trials of medical devices.
We are ready to offer all services for conducting clinical trials of medical devices, including: developing a study design, calculating the number of test samples, drawing up a test program, conducting tests on our database, writing a protocol and an act of clinical and laboratory tests based on the results of the research.
Clinical trials are conducted in full compliance with applicable standards.: Decree of the Government of the Russian Federation No. 1684 dated 11/30/2024 "On Approval of the Rules for State Registration of Medical Devices", Order of the Ministry of Health of the Russian Federation No. 885n dated 08/30/2021.
The procedure for assessing the conformity of medical devices for in vitro diagnostics in the form of clinical trials for the purpose of state registration of medical devices
Clinical trials of medical devices for in vitro diagnostics (clinical and laboratory tests) are conducted in laboratory conditions using patient biomaterial samples taken during the therapeutic and diagnostic process to verify the functional characteristics and effectiveness of the medical device when used in accordance with the purpose provided for in the manufacturer's documentation.
During conducting clinical and laboratory tests of a medical device for in vitro diagnostics we provide:
1. Analysis of documentation for a medical device for in vitro diagnostics;
2. Drawing up the test design and calculating the required number of samples;
3. Coordination of the program with the Applicant;
4. Conducting clinical and laboratory tests of medical device samples for in vitro diagnostics along with accessories necessary for the intended use of the medical device;
5. Evaluation and analysis of the data obtained and their compliance with the stated characteristics;
6. Revision of the manufacturer's (manufacturer's) operational documentation for an in vitro diagnostic medical device based on test results (if necessary);
7. Registration and issuance to the Applicant of an act of evaluation of the results of clinical and laboratory tests of a medical device for in vitro diagnostics.
During the tests, it is determined:
1. Compliance of a medical device for in vitro diagnostics with regulatory documentation, technical and operational documentation of the manufacturer;
2. Compliance of a medical device for in vitro diagnostics with the application intended by the manufacturer and the methods of use proposed by him;
3. Completeness and reliability of the safety and effectiveness characteristics of a medical device for in vitro diagnostics established by the regulatory documentation, technical and operational documentation of the manufacturer in accordance with the intended use of the medical device by the manufacturer, including its diagnostic sensitivity, specificity and reproducibility, as well as functional characteristics (analytical sensitivity, specificity, reproducibility, linearity and other characteristics), specified in the manufacturer's technical and operational documentation;
4. The quality of the medical product, the effectiveness and safety of its use.
We value your time, so we guarantee quality and an individual approach to each project.
Find out the cost and timing of testing specifically for your medical device by e-mail: info@aliquot.ru