Date: 25 and 26 September 2024
Location: Amsterdam, The Netherlands
Language: English
Price: € 1995,-
The ticket price includes access to the two-day training, lunch on both days, dinner and networking drinks on day one, and a certificate of participation.
The training can also be followed virtually upon request. Please contact marketing@qservegroup.com for terms and conditions.
Introduction
Artificial Intelligence (AI) is transforming industries worldwide, and the medical device sector is no exception. However, with great innovation comes the need for robust regulatory frameworks to ensure safety, transparent, and ethical use of AI technologies.
In this 2-day training program, we delve into the pivotal EU AI Act, a comprehensive horizontal legislation aimed at regulating AI across all member states.
Key Topics Covered
- Scope and Objectives: Understand the general principles of the EU AI Act and its regulatory and quality consequences, with a special focus on medical devices and health software.
- Risk-Based Approach: Explore the Act's risk classification system, ranging from minimal risk to high risk, and learn how different AI applications are regulated based on their potential impact.
- Compliance Requirements: Gain insights into the specific requirements for high-risk AI systems, including data governance, transparency, human oversight, and robustness.
- Regulatory Obligations: Learn about the roles and responsibilities of different stakeholders, including providers, deployers, authorized representatives, importers and distributors, in ensuring compliance with the EU AI Act.
- Impact on Innovation: Discuss the potential challenges and opportunities the Act presents for innovation in the AI and medical device sectors.
By the end of this 2-day training program, participants will have a comprehensive understanding of the EU AI Act and its relevance to their work in the medical device industry. They will be equipped with the knowledge to navigate the regulatory landscape effectively and ensure their AI innovations comply with the requirements as described in the EU AI Act. Join us to stay ahead of the curve and be a part of the conversation shaping the future of AI in healthcare.
Who Can Attend
- Regulatory Affairs VPs, directors and managers
- R&D Managers, R&D Engineers
- CTOs
- Regulatory Authorities
Learning Objectives
- Gain insight into the EU AI Act and compliance topics of AI Devices and IVDs.
- Learn how the AI Act affects your design, risk management and regulatory processes.
- Know who your stakeholders will be to bring your AI product into compliance.
- Have an idea how the AI Act impacts your innovation and time to market.
Program
25 September, 2024
- Opening Remarks by Gert Bos
- Introduction to the EU AI Act by Coenraad Davidsdochter
- Legal Implications of the AI Act by Erik Vollebregt (Axon Lawyers)
- Notified Body view on the AI Act by Malte Knowles Schmidt (TÜV SÜD Denmark)
- Impact of QMS on the AI Act by Henk-Willem Mutsaers
- Ethical Considerations of AI by Ildikó Vajda (Patiëntenfederatie) and Roland Bertens (Van Benthem & Keulen)
- Ask the Experts: Panel Discussion
- Diner and Networking Drinks
26 September, 2024
- Round-up of Day 1 by Gert Bos and Coenraad Davidsdochter
- Tecnhical File Impact of the AI Act by Coenraad Davidsdochter
- US versus EU requirements: Strategy for compliance by Gert Bos
- The AI Act in IVDs by Kristiane Schmidt
- How to Prepare for the Unknown? Leo Hovestadt (Elekta)
- Clinical Evaluation of AI Systems by Bianca Lutters
- Cybersecurity of AI Systems by Bingshuo Li
- Closing Drinks.
Limited seating available—book your ticket now!
Qserve Speakers