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Features of technological regulation for cardiac bioimplants

  • 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.

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Author:Nataliia ShchotkinaORCiD, Y. Palamarchuk, Iryna Skorokhod, Liudmyla DolinchukORCiD, Anatoliy SokolORCiD, Valentina MotronenkoORCiD, A. Besarab, N. Gorchakova, Marcus FrohmeORCiDGND, Michael HerzogORCiD
URN:urn:nbn:de:kobv:526-opus4-18248
DOI (Version of Record):https://doi.org/10.22494/cot.v11i1.147
ISSN:2311-021X
Parent Title (English):Cell and Organ Transplantology
Publisher:Institute of Cell Therapy
Place of publication:Kiev
Document Type:Article
Language:English
Year of Publication:2023
Publishing Institution:Technische Hochschule Wildau
Release Date:2023/11/16
Tag:cardiac bioimplant; manufacturing risk management; medical devices; quality system; technical regulation
Volume:11
Issue:1
First Page:26
Last Page:33
Source:Shchotkina N, Palamarchuk Y, Skorokhod I, Dolinchuk L, Sokol A, Motronenko V, Besarab A, Gorchakova N, Frohme M, Herzog M. Features of technological regulation for cardiac bioimplants. Cell Organ Transpl. 2023; 11(1):26-33. Available from: https://doi.org/10.22494/cot.v11i1.147
Faculties an central facilities:Fachbereich Ingenieur- und Naturwissenschaften
Dewey Decimal Classification:5 Naturwissenschaften und Mathematik / 57 Biowissenschaften; Biologie / 570 Biowissenschaften; Biologie
6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 617 Chirurgie und verwandte medizinische Fachrichtungen
Licence (German):Creative Commons - CC BY-NC - Namensnennung - Nicht kommerziell 4.0 International
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