Masterclass: Artificial Intelligence-based Medical Devices In-house Training

Keeping abreast of the changing regulatory landscape

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust and to ensure data is portable and qualitative. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

★★★★★ "Koen is a great speak who explains things very clearly with examples"

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Format: Bespoke training
CPD: 6 hours for your records (depending on your requirements)
Certificate of completion

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Overview

In this course, we’ll explore global legislative trends, providing an overview of current and proposed legislation and standards applicable to AI-based medical devices while taking lessons learnt from regulatory submissions of AI-based medical devices.

The European AI Act, soon to be upon us, will redefine specific medical devices as ‘high-risk AI systems’, ensuring they are legal, ethical, safe, and robust. Our course leader will demystify this Act, revealing its intricate interplay with existing medical device regulations, empowering manufacturers to secure their portfolios and gain a competitive edge. As you conclude this session, you’ll emerge enlightened about the AI Act’s profound impact on the medical device industry, its areas of consensus and ongoing debates.

As data is the lifeblood of AI-based medical devices we’ll immerse you in contemporary data management and governance practices, aligning with standards and the proposed European Data Act and European Health Data Space.

Lastly, we’ll explore adaptive AI-based medical devices, which dynamically adapt to clinical settings or individual patients. Discover their market presence, compliance with regulations, and strategies to earn trust with authorities.

This course offers a factual and comprehensive exploration of the evolving landscape of AI-based medical devices and the regulatory frameworks that govern them.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Benefits in Attending

Get up to speed with current regulations and standards on AI and data
Learn best practices for the development and regulatory submissions of AI-based medical devices
Understand the interplay between medical device, AI and data legislations
Gain insight into how upcoming legislations might impact your company’s portfolio
Learn how to convey in plain language how your company can comply and safeguard its product roadmaps

Who Should Attend

Global Regulatory Senior Managers
Team Lead in Global Medical Device Management
Principal Regulatory Affairs Specialist
Regulatory Affairs Managers
Safety Scientists
Scientific Support Specialists
Software Engineers
Head of Product Development
Device Technical Lead
IT Quality Advisers

Reviews of IPI's Masterclass: Artificial Intelligence-based Medical Devices training course

Koen is a great speak who explains things very clearly with examples

Jul 26 2024

Yisong Yin United States of America
Software Regulatory Affairs Specialist, Convatec

Jul 26 2024

Koen is a great speak who explains things very clearly with examples

Yisong Yin United States of America
Software Regulatory Affairs Specialist, Convatec

Jul 26 2024

Great knowledge of the material. Great speaker. I liked when the speaker gave insights into what will be expected of manufacturers and what legislation or publications are coming down the line and also his insights into the future

Denise McDermott Ireland
Regulatory Compliance Team lead, Compliance and Risks

Mar 6 2024

Koen has a breadth and depth of experience in this area, and was great at sharing that in an very accessible manner.

Michelle Galea United Kingdom
External Projects Manager, Optos plc

Nov 9 2023

I really appreciated the rich content of the slides, the level of information provided and the very clear overview of the regulator context, and the roadmaps.

Alexia Pleinecassagne Switzerland
RAQA Specialist, Medimaps Group SA

Nov 8 2022

This was exactly what I needed.

Mickael Vuagnoux Norway
QA Engineer, GE Healthcare

May 13 2022

Great presenter, great content. It's clear that Koen has extensive and very relevant experience in the field. He's an engaging presenter with useful insights.

Michelle Galea United Kingdom
External Projects Manager, Optos plc

United Kingdom