TY - JOUR A1 - Shchotkina, Nataliia A1 - Palamarchuk, Y. A1 - Skorokhod, Iryna A1 - Dolinchuk, Liudmyla A1 - Sokol, Anatoliy A1 - Motronenko, Valentina A1 - Besarab, A. A1 - Gorchakova, N. A1 - Frohme, Marcus A1 - Herzog, Michael T1 - Features of technological regulation for cardiac bioimplants JF - Cell and Organ Transplantology N2 - Patients with congenital heart defects and cardiovascular diseases are required new approaches to surgical intervention. The use of biological cardiac implants, which are made from the extracellular matrix, is a promising trend in modern regenerative medicine. These bioimplants can completely replace defective tissue or organs, and when manufactured with strict protocols and quality control measures, can be safe and effective for therapeutic applications. The process of manufacturing bioimplants involves various risks that need to be assessed and mitigated with ongoing monitoring and evaluation necessary to ensure the highest standards of quality. Overall, this study was successfully evaluated the requirements for introducing a new medical device into practice and created a technical file that meets all necessary documentation for certification. KW - cardiac bioimplant KW - quality system KW - manufacturing risk management KW - technical regulation KW - medical device Y1 - 2023 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:kobv:526-opus4-18248 SN - 2311-021X VL - 11 IS - 1 SP - 26 EP - 33 PB - Institute of Cell Therapy CY - Kiev ER -