5 – 7 May 2026
TRAINING TIMES
Learn how to define intended purpose and apply the main classification logics (EU MDR/IVDR software rules such as Rule 11-style reasoning, IMDRF SaMD categories, and AI qualification/classification triggers) so your regulatory pathway, evidence plan, and claims stay aligned.
Translate clinical needs into AI-ready design controls, including the full data pipeline as design inputs/outputs, plus human factors and clinical safety considerations that frequently cause real-world failures (misuse, overreliance, poor workflow fit).
Move past vague “AI risks” by using structured methods aligned with ISO 14971 and AI-focused risk concepts (bias, drift, opacity, misuse). Leave with a practical way to connect hazards → harms → controls → V&V evidence → technical documentation.
Set up the QMS capabilities regulators and Notified Bodies will expect—data governance, validation, monitoring, and controlled updates—so you can manage continuous learning/changes, demonstrate transparency, and handle conformity assessment and post-market obligations with confidence.
Three days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
Designed for professionals who want to enhance their expertise and advance their careers
