@article{ShchotkinaPalamarchukSkorokhodetal.2023, author = {Shchotkina, Nataliia and Palamarchuk, Y. and Skorokhod, Iryna and Dolinchuk, Liudmyla and Sokol, Anatoliy and Motronenko, Valentina and Besarab, A. and Gorchakova, N. and Frohme, Marcus and Herzog, Michael}, title = {Features of technological regulation for cardiac bioimplants}, series = {Cell and Organ Transplantology}, volume = {11}, journal = {Cell and Organ Transplantology}, number = {1}, publisher = {Institute of Cell Therapy}, address = {Kiev}, issn = {2311-021X}, url = {http://nbn-resolving.de/urn:nbn:de:kobv:526-opus4-18248}, pages = {26 -- 33}, year = {2023}, abstract = {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.}, language = {en} }