Management Forum Logo

Presented by
Management Forum

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

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. 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 + 3 more dates

Need help?  Enrol now

  • Format: Live online
  • CPD: 3 hours for your records
  • Certificate of completion

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

Enrol now

The EU Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers course will cover:

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

Enrol now

Koen Cobbaert

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.

More details

Book EU Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers Live online training

NEW higher discounts for multiple bookings - 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 online

13:00-16:00 UK (London) (UTC+00)
14:00-17:00 Paris (UTC+01)
08:00-11:00 New York (UTC-05)
Course code 12548

  • GBP 299 349
  • EUR 429 499
  • USD 501 579

Until 04 Oct

View basket 

1 Mar 2023

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 12550

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 25 Jan

View basket 

13 Jul 2023

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12551

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 08 Jun

View basket 

9 Nov 2023

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 12552

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 05 Oct

View basket 

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

United Kingdom

  • OKKO Health
  • Optos plc

Switzerland

  • Distalmotion

Enrol now

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
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy