Russian Federation
GRNTI 76.35 Прочие отрасли медицины и здравоохранения
The article reveals the main aspects of the safety monitoring of medical devices, the correct implementation of safety monitoring of medical devices in organization and prevention of adverse events, associated with medical devices. Likewise the analysis of incoming to Roszdravnadzor information as the result of safety monitoring of medical devices is given.
adverse event of medical device, safety monitoring of medical devices
1. Valeeva A.A., Sharikadze D.T., Borisova E.V. Poryadok soobscheniya v Roszdravnadzor informacii o neblagopriyatnyh sobytiyah, svyazannyh s primeneniem medicinskih izdeliy. - Upravlenie kachestvom v zdravoohranenii. - 2018. - № 3. - S. 28-35.
2. Valeeva A.A. Vidy i tipy neblagopriyatnyh sobytiy, svyazannyh s primeneniem medicinskih izdeliy: klassifikacii ISO i IMDRF. - Upravlenie kachestvom v zdravoohranenii. - 2018. - № 3. - S. 36-41.
3. Valeeva A.A., Sharikadze D.T., Borisova E.V. Poryadok provedeniya monitoringa bezopasnosti medicinskih izdeliy // Upravlenie kachestvom v zdravoohranenii. - 2018. - № 3. - S. 24-27.
4. Valeeva A.A., Ivanova T.V. Klyuchevye aspekty pravil provedeniya monitoringa bezopasnosti, kachestva i effektivnosti medicinskih izdeliy v ramkah Evraziyskogo ekonomicheskogo soyuza. - Vestnik Roszdravnadzora. - 2016. - № 5. - S. 24-27.
