AI Systems as Medical Devices

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

WHY SHOULD YOU ATTEND?

Get the classification right the first time

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.

Build safer AI by design—beyond generic software controls

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).

Run defensible risk management for AI-specific hazards

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.

Be audit-ready for scale-up, oversight, and post-market reality

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.

OUR ONLINE TRAINING EXPERIENCE INCLUDE

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.

WHO IS THIS TRAINING FOR?

Designed for professionals who want to enhance their expertise and advance their careers

Regulatory professionals

Quality assurance professionals

Clinical professionals

Design & development professionals

Technical (software/data/engineering) professionals

KEY TOPICS

Global regulatory requirements for AI as SaMD and AIMD

EU AI Act, MDR/IVDR intersections, FDA Good Machine Learning Practice, IMDRF

Qualification and classification triggers for AI systems

TRAINER

James Pink

Health Sciences and Medical Devices Consultant

James Pink has over 25 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assuranceprograms for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

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TRAINING AGENDA

AI Systems as Medical Devices

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