AI-Assisted Post-Market Surveillance and Signal Detection

What Regulators Will Still Expect Humans to Defend

Examine how AI-assisted post-market surveillance supports signal evaluation while organizations remain responsible for complaint assessment, MDR decisions, documentation, and regulatory justification.

EXCLUSIVE: Get your team to

attend for just $ 390.

Individual registrations available too.

COURSE OVERVIEW & STRUCTURE

More signals now require stronger human judgment.

Post-market teams routinely determine whether emerging safety information supports investigation, MDR reporting, field action, or continued surveillance under regulatory expectations. The session structures AI-assisted signal evaluation, complaint review, escalation rationale, documentation practices, and human accountability throughout post-market surveillance activities.

The session follows the progression from incoming post-market information through signal detection, evaluation, escalation, documentation, and regulatory justification. Practical discussion focuses on where AI contributes to analysis, where human judgment remains essential, and how organizations support safety-related conclusions with documented evidence.

WHAT YOU’LL LEARN

Supporting MDR decisions beyond algorithm outputs

AI-assisted signal detection within PMS programs
Complaint trends and emerging safety signals
MDR reporting and escalation thresholds
Human review of AI-generated findings
Managing false positives and data variability
Evaluating evidence supporting post-market decisions
Documentation for AI-assisted surveillance activities
FDA and EU MDR expectations for PMS governance

WHO SHOULD ATTEND

Designed for professionals responsible for evaluating, documenting, reviewing, or defending post-market safety decisions and surveillance activities.

Quality Assurance

Regulatory Affairs

Post-Market Surveillance

Manufacturing

Operations

Complaint Handling

Product Safety

Risk Management

Compliance

Vigilance

FACULTY

Meredith Crabtree

Meredith Crabtree brings more than 30 years of experience across pharmaceutical, medical device, biologics, laboratory, and related regulated industries. Her work supporting recalls, regulatory assessments, third-party inspections, quality systems, and product reviews provides practical insight into complaint evaluation, post-market oversight, regulatory documentation, and safety-related decision making in evolving AI-assisted environments.

AFTER YOU REGISTER

Everything related to your course lives in one place.

FDB1417

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After you register your seat, our team organizes everything for you; from access to certification – “from one place”.

You receive a confirmation and your course appears instantly in your TalkFDA dashboard.
Your course page becomes your central hub where you can join the session, access materials, and manage your learning.
At the scheduled time, simply click Join Session and you’ll be connected to the live Webex session with the instructor.
After the session, the playback becomes available on the same course page so you can revisit important sections.
Complete the course and your certificate is unlocked automatically in your learning history.

For Teams Seeking Deeper Implementation Support

Customized training is also available through

TalkFDA Elite Training Labs.

This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.

Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.

AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to Defend

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