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EU (European Union) Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers Training Course

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. 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.

8 Nov 2022

& 1 Mar 2023 , 13 Jul 2023 , 9 Nov 2023

Book now

Details

Overview

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. 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.

Benefits in Attending

  • Get up to speed with the proposed regulation
  • Understand the impact on machine learning medical devices
  • Gain an insight into this rapidly changing environment
  • Develop a competitive advantage

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
  • Device Technical Lead
  • IT Quality Advisers

Programme

Welcome and introduction

Geopolitical considerations of AI legislation

Introduction to the proposed European AI Act

Impact of the proposed AI Act on medical device manufacturers

International overview of legislation affecting machine learning medical devices

Standardisation on AI and related data

Future perspectives

Q & A

Presenter

Koen Cobbaert (More...)

Koen Cobbaert works part-time for Philips as a quality, regulatory and standards expert. Koen specializes in health software and views tech regulations through the computational lens. He enjoys giving training and lectures and thrives on solving complex regulatory challenges.

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, New Technologies and Annex XVI devices 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). 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 delegated as Belgian expert to IEC JTC 1/SC 42 on artificial intelligence, ISO/TC 121/SC 3/JWG 12 on home respiratory equipment, ISO/TC215/JWG7 on health informatics, and to the IEC SC62A advisory group on software, networks and artificial intelligence.

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.

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NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate
  • 40% off the 3rd delegate
  • 50% off the 4th delegate
8 Nov 2022
Live webinar
13:00-17:00
UK (London)
8 Nov 2022
Live webinar
13:00-17:00
UK (London)
GBP 349 299
EUR 499 429
USD 579 501
Until 4 Oct*
Enrol now
to attend
Live webinar
1 Mar 2023
Live webinar
09:30-17:00
UK (London)
1 Mar 2023
Live webinar
09:30-17:00
UK (London)
GBP 599 499
EUR 859 719
USD 970 814
Until 25 Jan 23*
Enrol now
to attend
Live webinar
13 Jul 2023
Live webinar
09:30-17:00
UK (London)
13 Jul 2023
Live webinar
09:30-17:00
UK (London)
GBP 599 499
EUR 859 719
USD 970 814
Until 8 Jun 23*
Enrol now
to attend
Live webinar
9 Nov 2023
Live webinar
09:30-17:00
UK (London)
9 Nov 2023
Live webinar
09:30-17:00
UK (London)
GBP 599 499
EUR 859 719
USD 970 814
Until 5 Oct 23*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 3 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

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Previous customers include...

  • Distalmotion
  • Okko Health
  • Optos plc

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, May 22