Features of technological regulation for cardiac bioimplants

Cell and Organ Transplantology. 2023; 11(1):26-33.
DOI: 10.22494/cot.v11i1.147

Features of technological regulation for cardiac bioimplants

Shchotkina N.^1,3, Palamarchuk Y.¹, Skorokhod I.³, Dolinchuk L.², Sokol A.¹, Motronenko V.¹, Besarab A.¹, Gorchakova N.², Frohme M.³, Herzog M.³

¹National Technical University of Ukraine “Igor Sikorsky Kyiv Polytechnic Institute”, Ministry of Education and Science of Ukraine, Kyiv, Ukraine
²O.O. Bogomolets National Medical University, Kyiv, Ukraine
³Technical University of Applied Sciences Wildau, Wildau, Germany

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.

Key words: cardiac bioimplant; quality system; manufacturing risk management; technical regulation; medical devices

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How to cite

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

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