<?xml version="1.0" encoding="utf-8"?>
<export-example>
  <doc>
    <id>1824</id>
    <completedYear>2023</completedYear>
    <publishedYear/>
    <thesisYearAccepted/>
    <language>eng</language>
    <pageFirst>26</pageFirst>
    <pageLast>33</pageLast>
    <pageNumber/>
    <edition/>
    <issue>1</issue>
    <volume>11</volume>
    <type>article</type>
    <publisherName>Institute of Cell Therapy</publisherName>
    <publisherPlace>Kiev</publisherPlace>
    <creatingCorporation/>
    <contributingCorporation/>
    <belongsToBibliography>1</belongsToBibliography>
    <completedDate>--</completedDate>
    <publishedDate>--</publishedDate>
    <thesisDateAccepted>--</thesisDateAccepted>
    <title language="eng">Features of technological regulation for cardiac bioimplants</title>
    <abstract language="eng">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.</abstract>
    <parentTitle language="eng">Cell and Organ Transplantology</parentTitle>
    <identifier type="issn">2311-021X</identifier>
    <identifier type="urn">urn:nbn:de:kobv:526-opus4-18248</identifier>
    <enrichment key="opus.import.date">2023-11-16T08:14:14+00:00</enrichment>
    <enrichment key="opus.source">sword</enrichment>
    <enrichment key="opus.import.user">sword</enrichment>
    <enrichment key="DOI_VoR">https://doi.org/10.22494/cot.v11i1.147</enrichment>
    <enrichment key="SourceTitle">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</enrichment>
    <licence>Creative Commons - CC BY-NC - Namensnennung - Nicht kommerziell 4.0 International</licence>
    <author>Nataliia Shchotkina</author>
    <author>Y. Palamarchuk</author>
    <author>Iryna Skorokhod</author>
    <author>Liudmyla Dolinchuk</author>
    <author>Anatoliy Sokol</author>
    <author>Valentina Motronenko</author>
    <author>A. Besarab</author>
    <author>N. Gorchakova</author>
    <author>Marcus Frohme</author>
    <author>Michael Herzog</author>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>cardiac bioimplant</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>quality system</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>manufacturing risk management</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>technical regulation</value>
    </subject>
    <subject>
      <language>eng</language>
      <type>uncontrolled</type>
      <value>medical device</value>
    </subject>
    <collection role="ddc" number="570">Biowissenschaften; Biologie</collection>
    <collection role="ddc" number="617">Chirurgie und verwandte medizinische Fachrichtungen</collection>
    <collection role="institutes" number="">Fachbereich Ingenieur- und Naturwissenschaften</collection>
    <collection role="open_access" number="">open_access</collection>
    <collection role="Import" number="import">Import</collection>
    <collection role="green_open_access" number="3">Diamond Open Access</collection>
    <thesisPublisher>Technische Hochschule Wildau</thesisPublisher>
    <file>https://opus4.kobv.de/opus4-th-wildau/files/1824/JCOT-2023-11-1_03.pdf</file>
  </doc>
</export-example>
