- IVDs
Virtual manufacturing (Company A is selling an IVD as its own, made by company B) has been and still is a very common practice in the IVD world. This was facilitated by the self-certification of most IVDs under the EU-IVD Directive. This presentation will explore whether this practice will still be possible under the IVDR and how to best manage the relationship between the legal manufacturer and the contract manufacturer.
Speaker
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.