Head of the Testing Laboratory for in vitro diagnotic medical devices
Paul-Ehrlich-Institut, Germany
Heinrich Scheiblauer: Head of the Testing Laboratory for In Vitro Diagnostics at the Paul Ehrlich Institute (PEI-IVD). Since more than 30 years, experience in virology on influenza virus pathogenicity, viral safety of plasma derivatives and blood products, and diagnostics. Thirty-four scientific publications. Since 2000, collaboration with notified bodies under IVDD 98/79/EC for batch testing, product assessment and on-site audits. As part of the WHO Collaborating Center at PEI for quality assurance of blood products and in vitro diagnostics at PEI, development of biological standards.
Member of the European Commission Expert Panel in the field of medical devices and in vitro diagnostics, in the MDCG working groups for standards and IVD, and EU representative for IVD in the IMDRF.
Currently in the application process for an EU Reference Laboratory under the IVD Regulation 2017/746.
Disclosure information not submitted.
Conformity Assessment of Class D Devices: What is the Current Status?
Thursday, May 11, 2023
16:45 – 17:45 CEST