Technical trials are carried out to ascertain that a medical device complies with the general requirements related to safety, efficacy, and labelling, and has the necessary technical and operational documentation.
The testing laboratory of the Center for Diagnostics and Telemedicine is included in the Register of the Entities Certified for Technical Trials (unique record number: RA.RU.22ЭР08). The Center's Notice on Initiating Business Activities (technical trials of medical devices) was registered with the Federal Service for Supervision in Healthcare on April 08, 2022 No. 27941, and entered in the register of notifications.
Please send your technical trial application and your questions to ctmd@zdraz.mos.ru
Author of the National standard GOST R 59921.2-2021 “Artificial intelligence systems in clinical medicine. Part 2. Guidelines and methodology of technical trials”
The experience accumulated during the Computer Vision Moscow Experiment over 2020-2022. Fifty-two completed functional tests of artificial intelligence systems from 17 developers, and 6.4 million analyzed studies
The Center is the core organization of the PK01/TK164 Subcommittee “Artificial Intelligence in Healthcare”. The Subcommittee is involved in the development of national standards in clinical medicine
The Center oversees the entire testing process and keeps track of feedback
The Department of Innovative Technologies established the Sector of Clinical Trials to oversee the technical trial procedures