Leonard Buchner

Leonard Buchner

Biostatistics Expert

US Principal Consultant

Leonard is part of the US Regulatory Affairs team providing biostatistical and clinical perspectives from a manufacturer’s point of view having led and served on multiple successful product core teams.

The key expertise areas of Leonard

  • Biostatistical support
  • US FDA submissions, pre-submissions, IDE, 510(k), PMA
  • CE-Mark Technical File
  • Product development life cycle management
  • Verification, validation and optimization study designs and analyses
  • Clinical operations
  • Team management

Before Qserve

Leonard has over 35 years’ experience working in the IVD and medical device industries. Working with small startups all the way to large multinational companies. Some product areas include, immunoassay, flow cytometry, lateral flow, PCR, array and next generation sequencing, peripheral vascular and drug releasing pulmonary devices. He has worked with all levels of complexity from CLIA waived products to companion diagnostic products. Leonard is experienced at assessing whether or not there is sufficient evidence to support the product claims.

He earned his B.S. in Biology (UCDavis), M.S. in Biology (CalPolySLO) and M.S. in Biometry (Medical University of South Carolina).

Learn more about our services within Regulatory Affairs

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