12 – 14 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
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
