Dr. Maurizio Suppo, Principal Consultant & VP of QARAD, a Belgium-based consulting company specialized in EU legislations for medical devices and in-vitro diagnostic products.
Areas of expertise include, EU and non-EU regulations, Quality Systems – ISO 9001 / ISO 13485, Quality System audits (9001/13485), Authorized Representative services, performance evaluation studies, multi-language labelling, international standards and MDSAP.
Dr. Suppo is a trained auditor in ISO 13485: 2016 and MDSAP. Up to date Dr. Suppo has performed a total of 13 MDSAP mock audits of both IVD and Medical Device manufacturers. Each MDSAP mock audit lasted for full five days for a total of 520 hours of MDSAP auditing experience.
In November 2018 Dr. Suppo has been nominated one of the 5 finalists for the TOPRA (*) 2018 Awards for Regulatory Excellence in the category of Contribution which recognizes regulatory professionals who have made a significant and consistent contribution to a team, project, regulatory science, or the profession.
*The Organization of Professionals in Regulatory Affairs (www.topra.org).
Dr. Suppo is a member of European Commission IVD Technical group defining EU regulatory issue for IVDs & the European Association of Authorized Representatives (EAAR)
This webinar provides a high-level overview of the new In-vitro Diagnostics EU Regulation (IVDR) that came into effect as of May 26th, 2022, and the implications for institutions offering laboratory-developed tests (LDTs).
