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Certified Laboratory

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Certified equipments
The group ensures the preservation of the installed quality management system (QMS) at the laboratory for Biomedical Microtechnology of Prof. Dr. Thomas Stieglitz according to DIN EN ISO 13485:2016-08 "Medical devices - Quality managment systems - Requirements for regulatory purposes". The scope of the QMS is "Design and Development, Production and Distribution of Implantable Electrodes" and is certified by the TÜV SÜD Product Service GmbH (No. Q5 098148 0002 Rev. 01). Our laboratory does NOT act as manufacturer according to the REGULATION (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. We provide a comprehensive range of products and services of design, develop and manufacture neurotechnical implants. We provide this expertise and infrastructure to our customers.
TeamCL
  • Thomas Stieglitz (laboratory head)
  • Paul Čvančara (quality management officer)
  • Patrick Kiele (deputy quality management officer)
  • Awal Mamouda (clean room responsible)
  • Calogero Gueli (machine responsible)
  • Cristian Pasluosta (machine responsible)
  • Linda Rudmann (machine responsible)
  • Jennifer Schulte (machine responsible)
  • Nina Stobbe (documentation)
  • Benedikt Szabo (machine responsible)

Contact
Paul Čvančara
Quality management officer
E-Mail: paul.cvancara@imtek.uni-freiburg.de
Telephone: +49 (0)761 203 67635
 
Laboratory for Biomedical Microtechnology
Department of Microsystems Engineering
University of Freiburg - IMTEK
IMBIT - NeuroProbes
Georges-Köhler-Allee 201
Room: 01.005
79110 Freiburg
Germany
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