LIVE WEBINAR
AI-Assisted Post-Market Surveillance and Signal Detection
What Regulators Will Still Expect Humans to Defend
- July 10, 2026
- 11 AM Eastern Time US
- 3 PM GMT
- 90 Minutes
- Streaming Available
- 90 Minutes
- Certificate of Completion
Designed for teams responsible for interpreting post-market information, evaluating safety signals, managing complaints, or supporting regulatory reporting activities.
ABOUT THE COURSE
Organizations increasingly receive AI-assisted signal outputs but must still determine whether available evidence supports escalation, reporting, investigation, or continued monitoring. This session structures oversight, evaluation, and documentation activities surrounding AI-supported surveillance outputs while maintaining accountability for safety-related decisions and actions.
The discussion begins with how AI-assisted tools contribute to signal identification across post-market data sources, then examines the decision-making activities that follow. Emphasis is placed on evaluating evidence quality, applying oversight, documenting rationale, managing uncertainty, and maintaining consistency across surveillance, escalation, reporting, and governance processes.
Key Areas Covered
- AI-assisted signal detection within PMS activities
- Complaint trends, adverse events, and emerging signals
- MDR reporting decisions and escalation thresholds
- Evaluating evidence supporting investigation or monitoring
- Human oversight of AI-generated safety findings
- Managing false positives and data variability
- Documentation supporting post-market decisions
- FDA and EU MDR expectations for PMS governance
Meredith Crabtree
Meredith Crabtree brings more than three decades of experience across regulated product lifecycles, including quality systems, recalls, inspections, regulatory assessments, and post-market activities. Her work supporting organizations through quality reviews, compliance evaluations, and regulatory scrutiny provides practical perspective on how safety signals are assessed, documented, escalated, and justified within regulated environments.
What Happens After You Reserve Your Seat
Your registration is managed by our events team to ensure a coordinated and seamless experience.
- A confirmation email outlines onboarding details and next steps
- Access credentials are shared in advance so you are prepared before the session
- Handouts (where applicable) are provided ahead of time
- The training is delivered live via Webex with interactive participation and Q&A
- Certificates of completion are issued following the session
- For live + recording access, post-session availability is provided through TalkFDA
- Event support remains available for any access or logistics assistance
Access is provided in a structured and professionally supported format.
- A confirmation email outlines onboarding and next steps
- The complete session recording is delivered through TalkFDA
- Access is granted shortly after purchase so you can begin without delay
- Recording includes the full presentation and instructor-led discussion
- Certificates of completion are issued upon course completion
- Support remains available for any technical or access assistance
FDB1417
© All rights reserved