Presented by
Management Forum
Masterclass: Artificial Intelligence-based Medical Devices 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 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.
9 November 2023
+ 6 March 2024, 26 July 2024, 7 November 2024
from £549
- Format: Live online
- CPD: 6 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 regulations on AI and data
- 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 Development
- Device Technical Lead
- IT Quality Advisers
The Masterclass: Artificial Intelligence-based Medical Devices 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.
Book Masterclass: Artificial Intelligence-based Medical Devices 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*
Please contact us for pricing if you are interested in booking 5 or more delegates
9 November 2023
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 12552
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 05 Oct
- 4 hours of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
6 March 2024
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 13573
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 31 Jan
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
26 July 2024
Live online
09:00-16:00 UK (London) (UTC+01)
10:00-17:00 Paris (UTC+02)
04:00-11:00 New York (UTC-04)
Course code 13804
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 21 Jun
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
7 November 2024
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 14032
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 03 Oct
- 4 hours of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* 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.
Reviews of IPI's Masterclass: Artificial Intelligence-based Medical Devices training course
This was exactly what I needed.
Nov 8 2022
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
- BMJ Publishing Group Ltd
- Convatec
- Corin Limited
- Janssen Pharmaceutical Companies of Johnson & Johnson
- OKKO Health
- Optos plc
- Team Consulting Ltd
Belgium
- Medtronic
- The Medtech Group Inc
Norway
- GE Healthcare
Switzerland
- Distalmotion
United States of America
- Butterfly Network
