Impact of the new EU IVD-Regulation on the daily life of the clinical flow cytometry laboratory
декабря 3, 2020
The new European IVD Regulation 2017/746 is paved with good intentions. However, some of them may potentially render the life of clinical Flow cytometry laboratories a whole lot more complex than what it is now. This presentation will provide a high-level broad coverage of the new EU IVD Regulation and will specifically elaborate on how the EU Authorities will regulate the vast majority of the Laboratory Developed Tests which are currently done in Europe on a daily base.
Maurizio Suppo, Ph.D.
Maurizio Suppo (born 1960, Italian citizen) obtained his Ph.D. in molecular biology from the University of Turin (Italy) in 1985. Maurizio has more than 34 years of experience in the field of regulatory affairs and quality systems in the In-Vitro Diagnostic industry. He has been the Director of the European Diagnostic Manufacturers Association (EDMA) and, in that role, he represented the IVD industry position in the drafting of the European IVD Directive 98/79/EC. His knowledge and experience in RA&QS go beyond the European borders. Trained ISO-9001 & 13485:2016 auditor Dr. Suppo is also an expert MDSAP auditor with more than 500 MDSAP audit hours as a lead auditor.
Maurizio Suppo joined Qarad in July 2012 and became partner and co-owner in January 2016. He is a regular speaker and chairman at international conferences and published more than 20 articles in the specialized press. He is fluent in Italian, English, French with a good knowledge of Spanish.