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Andreas Kalchschmid-Lehmann, MSc

Co-Lead IVD and Consultant QMS
Johner Institut GmbH

Andreas Kalchschmid-Lehmann, M.Sc., is an expert in in-vitro diagnostics at the Johner Institute with more than 17 years of practical experience in molecular diagnostics.
He is the author of the book "ISO 13485 - Obstacle or Opprotunity?" and has relevant experience in other QM systems, including ISO 17025, ISO 15189, MDSAP and CFR 820.
As a laboratory manager he gained detailed knowledge of processes in a routine diagnostic laboratory and as a former quality manager he knows how to successfully set up and live a QMS for IVDs.
He worked as a product specialist and lead auditor for a large Notified Body where he assessed technical documentation of IVDs and QM systems.
Currently he assists stakeholders in the medical device industry as a consultant for the Johner Institute.

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