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Sebastian Grömminger

Principal Consultant IVD
Entourage GmbH

Sebastian Groemminger  (PhD)
Molecular biologist and expert in the field of molecular genetic in-vitro diagnostic medical devices.
(+10-year experience)
Expert on in vitro diagnostics, medical devices, quality management, regulatory affairs and risk management
Extensive knowledge about
- software development lifecycle process implementation according to EN (IEC) 62304,
- usability evaluation according to EN (IEC) 62366
- risk management compliant to EN ISO 14971 and
- European Regulation 2017/746 (IVDR).
Detailed experience in conformity assessment and performance evaluation of IVD Medical Device Software analyzing and interpreting Next Generation Sequencing (NGS) data. Assay development according EN ISO 13485 and clinical performance evaluation based on quantitative PCR methods.
At ENTOURAGE, he supports clients in the certification, development, and maintenance of QM systems according to EN ISO 13485, writing of technical documentations, as well as in the implementation of the standards EN 62304 and EN ISO 14971, and the regulatory strategy for the approval of in-vitro diagnostic medical devices.

Disclosure information not submitted.

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