Within the framework of the "State regulation in the field of circulation of medicines and medical devices – FarmMedObrashchenie (PharmMedCirculation) 2020" XXII National Conference, the results of the "Safety of medical devices for the benefit of people" competition were announced. The competition was organized by the FBGU Center for Monitoring and Clinical and Economic Expertise (FGBU CMIKEE) together with Roszdravnadzor.
The purpose of the Competition was:
- to organize preventive activities in the field of production and circulation of medical devices;
- to improve the quality, efficiency, and safety of medical devices approved for circulation on the territory of the Russian Federation;
- to support effective and meaningful projects;
- to support the best practices in implementing quality management systems in production.
The competition was held in an open format in two stages. During the first one, the nominees presented their projects to the public, while in the course of the second stage they had to solve situational problems answering questions posed by the Expert Commission. Foreign and Russian manufacturers of medical devices were invited to participate in the competition; as a result, 14 companies from various areas took part in it.
The jury of the competition included: Deputy Head of Roszdravnadzor, Dmitrii Pavliukov; Head of Department of organization of state control and registration of medical devices of Roszdravnadzor, Elena Astapenko; Chief Officer of FGBU "CMIKEE", Igor Ivanov; Deputy Chief Executive Officer of FGBU "CMIKEE", Igor Kazmin, and other experts in surveillance of medical devices.
Our company presented the Artificial intelligence in healthcare: Challenges and solutions. Webiomed project report. We revealed the main problems in the creation and implementation of software medical devices based on artificial intelligence technology as well as technological and organizational approaches that are used in Russia in order to solve these problems.
During the speech, we have emphasized the importance of enhancing the credibility of our software in the eyes of medical professionals.
According to the results of the competition, K-SkAI took second place.
The regulation and safe use of software medical devices is an urgent issue for our country. Roszdravnadzor, together with experts and development companies, is constantly seeking the balance between surveillance activities and providing users with innovative solutions, including those based on artificial intelligence, as well as trying to ensure simple access to the market for such products.
We are actively involved in these activities. That is why as soon as we learned about this competition for the best practices in safety and effectiveness of medical devices, we applied immediately. Of course, we are very happy to become one of the winners and take the second place. It is very honorable for our team, and we want to thank the organizers of the competition for the opportunity to participate,” stated Alexander Gusev, Chief business development officer of Webiomed.
Source (in Russian): roszdravnadzor.gov.ru/news
The additional information may be obtained (in Russian):
o Official website of Roszdravnadzor: https://roszdravnadzor.gov.ru/
o Official website of the FGBU CMIKEE: http://cmkee.ru/
o Official website of ФармМедОбращение 2020 (PharmMedCirculation): http://www.phmo.ru/