MEDevice Silicon Valley (San Jose)
Back to EventsMEDevice Silicon Valley
November 18 - 19, 2026
San Jose, CA
Medicept Founder F. David Rothkopf will speak during the event:
This Is Not Your Father's FDA Inspection
Wednesday, November 18 - Design Studio Theater (805)
In February 2026, FDA implemented the Quality Management System Regulation (QMSR), retired the longstanding QSIT inspection model, and introduced a new inspection technique under Compliance Program Manual CP 7382.850. Unlike ISO 13485 certification or MDSAP audits, this risk-driven approach evaluates six QMS Areas and four OAFRs, with a sharp focus on data analysis, trending, continuous improvement, management oversight, and whether a company's quality system is actually working.
Drawing on experience from more than 60 FDA inspections, including inspections conducted under the new methodology, this session will explore how FDA's approach has changed, what manufacturers should expect, and how to prepare for their next inspection.
Planning to Attend MEDevice Silicon Valley?
The Medicept team will be attending MEDevice Silicon Valley and looks forward to connecting with medical device industry professionals. Whether you're navigating regulatory challenges, strengthening your quality management system, or preparing for an upcoming FDA inspection, we'd welcome the opportunity to discuss your goals.
Connect with our team to schedule a meeting during the event.