Rimsys RegUP - Boston
Join Rimsys for RegUp Boston at Democracy Brewing!
By Rimsys
Date and time
Thursday, September 29, 2022 · 12 - 4pm EDT
Location
Democracy Brewing
35 Temple Place Boston, MA 02111Join Rimsys for RegUp Boston at Democracy Brewing!
Democracy Brewing
35 Temple Place Boston, MA 02111Join Rimsys for a RegUP (Regulatory Meetup) at Democracy Brewing in Boston on Thursday, September 29th at 12:00 pm. We’ll network, discuss medtech regulatory trends and best practices, and sample some excellent craft brews. Attendance is free for Rimsys customers and qualified guests.
Agenda
12:00 - 12:30pm Welcome: Increasing confidence in regulatory planning
Many regulatory challenges are driven by a lack of visibility into regulatory timelines, resources, and needs. A comprehensive regulatory data strategy can help RA teams build more resilient plans, and shift their organizational posture from reactive to proactive.
12:30 - 1:15pm Catered lunch
1:15 - 1:45pm TBD Regulatory best practices case study
1:45 - 2:15 MDR/IVDR information essentials
MDR/IVDR compliance remains top of mind for RA teams. New information requirements including GSPRs, UDI/EUDAMED, and Post-market surveillance and reporting require a new approach to regulatory information management.
2:15 - 4:00pm Brewery tour, tasting, and networking
Speakers
James Gianoutsos - Founder & CEO, Rimsys
Bruce McKean - Director, Regulatory, Rimsys