Are you new to EU regulations? On your way to IVDR compliance?
Our team of experts can address all your doubts or concerns. We offer advice on how to deal with observations and comments from Notified Bodies.
From July 17 to July 21, we will tour the US West Coast for the AACC Annual Scientific Meeting, so we can organize in-house training sessions at your convenience. Don’t miss this exclusive opportunity!
Don’t miss the opportunity to discuss your doubts or concerns with our experts or to request specific training on some of the most complex IVDR topics.
with 2 senior consultants who perfectly complement each other
Maurizio Suppo
Maurizio Suppo obtained his Ph.D. in molecular biology from the University of Turin (Italy) in 1985. He joined Qarad, part of the QbD Group in July 2012 and became partner and co-owner in January 2016. He is a regular speaker and chairman at international conferences.
Maurizio has more than 30 years of experience in the field of regulatory affairs and quality systems. He has held executive positions at Sorin Biomedica (now DiaSorin), Becton Dickinson, Dade Behring, Siemens Healthcare.
Maurizio Suppo has also been the Director of the European Diagnostic Manufacturers Association (EDMA) and he has played a significant role in the development of the European IVD Directive 98/79/EC.
His knowledge and experience in Regulatory Affairs and Quality systems go beyond European borders.
Pieter Bogaert
Pieter Bogaert is an IVD specialist with a wealth of experience in flow cytometry. Pieter graduated with a Ph.D. in Biotechnology at Ghent University, after which he stayed on to work there.
He later expanded his knowledge by working as a Flow Cytometry specialist at BD Biosciences and Cerba Healthcare. Pieter has written multiple articles, published in various international, peer-reviewed journals.
Pieter’s responsibility is to ensure compliance of IVD product technical documentation with the European Regulation. This includes gap assessment and other consulting services, as well as technical file writing and compilation.
Given his previous professional experience, Pieter’s in-depth areas of expertise are medical laboratory devices, clinical flow cytometry reagents and instruments.
