MEDevice Boston
August 26–27, 2026
Thomas M. Menino Convention & Exhibition Center
Boston, MA
Medicept Founder Dave Rothkopf will speak at two sessions during the event:
This Is Not Your Father’s FDA Inspection
Wednesday, August 26
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. Internal audits, supplier audits, management reviews, and even past records are now open to inspection, making much of what companies learned from previous FDA inspections obsolete.
Drawing on experience from more than 60 FDA inspections—including four domestic and international inspections conducted under the new method as of April 2026—this session will explain how FDA’s approach has changed and how to prepare before your next inspection.
U.S. Regulatory Strategies Lab: Guided Exercises to Strengthen Your Regulatory Submissions for Market Entry
Thursday, August 27
2:00–3:30 p.m. ET
Conference Room 160A
Medicept Founder F. David Rothkopf will co-lead this interactive workshop with regulatory expert Kimberly Trautman.
Participants will evaluate a mock medical device and work through guided exercises to determine the appropriate FDA pathway. Teams will assess device classification, predicate strategy, risk profile, and timeline implications while considering how each decision could affect market entry.
Attendees will leave with a structured decision-making framework they can use to plan future regulatory submissions with greater clarity and confidence.
Planning to attend MEDevice Boston?
Medicept has an exclusive discount code to use during registration. Complete the form below to receive the code.
