心脏生物植入物技术调控特点

N. Shchotkina, Y. Palamarchuk, I. Skorokhod, L. Dolinchuk, A. Sokol, V. Motronenko, A. Besarab, M. Frohme, M. Herzog
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引用次数: 0

摘要

先天性心脏缺陷和心血管疾病患者需要新的手术干预方法。利用细胞外基质制成的生物心脏植入物是现代再生医学的一个有前途的趋势。这些生物植入物可以完全替代有缺陷的组织或器官,并且在严格的规程和质量控制措施下制造,可以安全有效地用于治疗应用。制造生物植入物的过程涉及各种风险,需要通过持续的监测和评估来评估和减轻风险,以确保最高的质量标准。总体而言,该研究成功地评估了将新医疗设备引入实践的要求,并创建了满足所有必要认证文档的技术文件。
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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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来源期刊
Cell and Organ Transplantology
Cell and Organ Transplantology Medicine-Transplantation
CiteScore
0.40
自引率
0.00%
发文量
8
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