On 5 April 2017, the European Parliament voted to adopt the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), the final step before the regulations are formally published in the Official Journal of the European Union in May. The deadlines to comply with the new regulations are May 2020 for the MDR and May 2022 for the IVDR.
Join your quality and regulatory colleagues from ASQ Northern California Biomedical Discussion Group and the RAPS San Francisco Bay Area Chapter for an informative and interactive session on the biggest changes coming your way in the new MDR and IVDR. Recertification credits/units can be claimed: six RAC recertification credits and 0.6 ASQ RU credits.
Representatives from major Notified Bodies and leading quality/regulatory consulting firms will provide us with the practical tools and tips needed to effectively plan, prepare and transition from the MDD/IVDD to MDR/IVDR, as well as what to do if your Notified Body doesn’t make the cut.
View program agenda.