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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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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

This course will cover:

Current legislative requirements for AI-based medical devices

  • International overview of legislation and guidance
  • Considerations for regulatory submissions
  • Initiatives by medical device regulators
  • Lessons learnt from regulatory submissions
  • Future perspectives

Europe’s proposed Artificial Intelligence Act

  • Geopolitical considerations of AI legislation
  •  Introduction to the proposed European AI Act

Europe’s proposed Artificial Intelligence Act con’d

  • Impact of the proposed AI Act on medical device manufacturers, clinicians, and patients
  • Interplay of proposed AI Act with medical device regulations

Standardization on AI and related data

  • Standards in support of the proposed AI Act
  • Interplay between horizontal and vertical standardization landscape
  • Standards for AI-based medical devices
  • Q&A

Data and Data Governance

  • European Data Act and European Health Data Space
    • Overview of the legislation
    • Impact on healthcare
  • European Health Data Space
    • Overview of the legislation
    • Impact on healthcare
  • State-of-the-art practices for Data Management and Data Governance
  • Q&A

Adaptive AI-based Medical Devices

  • Role of machine-learning enabled medical devices (MLMD) in healthcare
  • Adaptive AI-based medical devices
  • Learning during clinical use
  • Change considerations
  • Predetermined Change Control Plan
  • Significant changes to adaptive AI-based medical devices
  • Q&A

Koen Cobbaert
Philips Healthcare

Koen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents the industry at the European Commission and the IMDRF on matters related to software and artificial intelligence. He also contributes to various standardisation organizations focusing on software and artificial intelligence.

In the legislative domain, Koen chairs COCIR’s and DITTA’s software focus groups, representing its members at respectively the European Commission MDCG workgroups on Borderline and Classification and New Technologies and at the international level at the International Medical Device Regulators Forum (IMDRF) workgroup on artificial intelligence. Koen is also an advisor in the SaMD workgroup at the Global Harmonization Working Party (GHWP). Currently, Koen is engaged in various proposed EU legislation relating to artificial intelligence and data (AI Act, Machinery Regulation, General Product Safety Directive, Data Act, European Health Data Space…). Aside from various publications through trade associations, Koen also edited the book Software as a Medical Device, published through the Regulatory Affairs Professionals Society (RAPS).

In the standardization domain, Koen is a member of CEN-CENELEC’s Industry Advisory Forum, and he is delegated as a Belgian expert to IEC JTC 1 SC 42 on artificial intelligence, CEN-CENELEC JTC21 on artificial intelligence, ISO TC215 JWG7 on health informatics, and to the IEC SC62A Advisory group on Software, Networks, and Artificial Intelligence (SNAIG).

Koen has a Master of Science in electrical engineering and safety risk management. He has over 15 years of hands-on experience establishing regulatory and market-access strategies for medical device software, performing worldwide regulatory submissions, and moderating risk management and clinical evaluation for software applications for general radiology, oncology, neurology, cardiology, orthopaedics, and clinical pathology. He has worked on software applications for pattern recognition, computer-aided detection, reasoning engines, clinical pathways, and other clinical decision support systems, including mobile apps, embedded software, and software operating in the cloud.

More details

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
Software Regulatory Affairs Specialist, Convatec

Jul 26 2024

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

Yisong Yin
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
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
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
RAQA Specialist, Medimaps Group SA

Nov 8 2022

This was exactly what I needed.

Mickael Vuagnoux
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
External Projects Manager, Optos plc

United Kingdom

  • 42 Technology
  • BMJ Publishing Group Ltd
  • Convatec
  • Corin Limited
  • Intertek
  • Janssen Pharmaceutical Companies of Johnson & Johnson
  • OKKO Health
  • Optos plc
  • OrganOx Ltd
  • Team Consulting Ltd
  • Teva Pharmaceuticals

Denmark

  • Ambu
  • Ambu A/S
  • AMBU AS
  • Novo Nordisk AS

Sweden

  • Molnlycke Health Care
  • MOLNLYCKE HEALTH CARE AB
  • Nevro Limited

United States of America

  • Butterfly Network
  • Convatec
  • Split Rock Communications, LLC

Belgium

  • Medtronic
  • The Medtech Group Inc

Norway

  • GE Healthcare
  • Inventas

Switzerland

  • Distalmotion
  • Medimaps Group SA

Austria

  • MED-EL

Canada

  • Johnson & Johnson

Ireland

  • Compliance and Risks

Netherlands

  • Leica Biosystems

Spain

  • Ingecal

Run Masterclass: Artificial Intelligence-based Medical Devices Live online for your team

1 day

Typical duration

Pricing from:

  • GBP 450
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online
Contact us 

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy