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Complimentary Webinar
April 23, 2024 | 10:00 AM ET /4:00 PM UTC

High Risk AI under the European AI Act:
Must know strategies for Medical Device Companies to Achieve Regulatory Excellence

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Join our upcoming webinar on navigating the AI Act, specifically tailored for those with Medical devices with AI. This session is designed to clarify high-risk AI applications within medical devices, helping your team to identify your regulatory responsibilities and plan your strategy effectively. 

We'll dive deep into the AI Act's regulatory framework, providing clear insights into compliance requirements, reporting obligations, and ensuring your AI-driven medical devices adhere to the necessary ethical and safety standards set by the legislation.

Learn about practical strategies for conducting risk assessments on AI technologies used in medical devices. We'll cover tools and methodologies for identifying potential risks, implementing mitigation strategies, and maintaining ongoing compliance throughout your product's lifecycle.

Additionally, we'll discuss how to future-proof your regulatory approach in the face of a rapidly evolving regulatory landscape. Discover how to monitor and adapt to future amendments in the AI Act, engage proactively with regulatory bodies, and foster a culture of compliance within your organization.

WHO SHOULD ATTEND:

  • Medical Device companies with AI, Head of RAQA, Head of R&D, Software as a Medical Device companies, C Suite & Cofounders

WHAT YOU WILL LEARN:

  • What qualifies as high-risk AI under the AI Act, focusing on applications within medical devices. Better understand criteria and classifications, helping teams to accurately identify their obligations and strategize accordingly.
  • The AI Act’s Regulatory Framework with insights into compliance requirements, reporting obligations, and how to ensure your AI-driven medical devices meet the necessary ethical and safety standards set by the legislation.
  • Discover effective strategies for conducting risk assessments on AI technologies in medical devices, ensuring compliance with the AI Act. Practical tools and methodologies for identifying potential risks, implementing mitigation strategies, and maintaining ongoing compliance through the product lifecycle.
  • How to future-proof your Regulatory Approach to stay ahead of the curve in a rapidly evolving regulatory landscape. How to monitor and adapt to future amendments in the AI Act, engage with regulatory bodies proactively, and foster a culture of compliance.

SPEAKER

Vankrunkelsven_Ann

Ann Vankrunkelsven
RA/QA Manager
Matrix Requirements

Ann Vankrunkelsven is a driven and dynamic RA/QA professional who thrives on new challenges and making a positive impact in the world. With a PhD in Bio-engineering, she has always been fascinated by the intersections of science, innovation, and business. After years of honing her skills in Regulatory Affairs and Quality Assurance, Ann has become a true master, often lecturing at Ecole Polytechnique de Louvain.

Currently RA/QA Manager at Matrix Requirements, Ann is a trailblazer who never settles for the status quo. She is passionate about helping customers & businesses succeed with Regulatory Affairs and Quality Assurance & firmly believes that improvement of the quality system and implementation of regulations need to stay practical to be successful. An entrepreneur at heart, Ann built her own business, VR Projects which aims to help global businesses understand Regulatory and Quality Affairs.

Leon Doorn

Leon Doorn
Quality & Regulatory Affairs
Independent Consultant

Leon Doorn has been working for more than 15 years in the medical device industry within quality and regulatory affairs, and currently works as an independent consultant. Over the past 10 years he has gained substantial experience working with Software Medical Devices, and in particular devices enabled by Artificial Intelligence. In addition, Leon is the Chair of the Dutch working group in Medical Device and AI for NEN, and an expert within the JTC 21, SC 42 and TC 61 committees supporting the development of standards around AI (within ISO/IEC & CEN/CENELEC). 

Tatjana_Evas

Dr. Tatjana Evas
Legal & Policy Officer
European Commission

Dr. Tatjana Evas is a Legal and Policy Officer in the European Commission (DG CNECT), AI Policy Development and Coordination Unit. She is one of the key members of the European Commission’s drafting and negotiating team for the AI Act, primarily overseeing the technical requirements, standardization, conformity assessment, market surveillance, and cybersecurity. Furthermore, she is responsible for the coordination and development of guidance on the relationship between the AI Act and sectoral legislation, notably on medical devices, machinery regulation, cybersecurity, and automotive legislation. Dr. Evas’ portfolio in the Unit also includes technical work with standardization organizations (CEN/CENELEC JTC-21 and ISO SC-41) and international cooperation on AI. She holds a position as vice-chair of the OECD Working Party on Artificial Intelligence Governance (AIGO) and represents the Commission in work with the G7, UN, Canada, and the United States. Tatjana holds a PhD in law from the University of Bremen (Germany). Before joining the European civil service in 2015, she had professional experience in academia and the non-governmental sector, working on the intersection of technology and law.

Tibor Zeichmeister

Tibor Zechmeister
Regulatory Compliance
Entrepreneur

Tibor Zechmeister is an entrepreneur in the medical device sector with over a decade of experience. He specializes in regulatory compliance and quality management systems. His role as an external auditor and founder in the HealthTech space has equipped him to adeptly guide startups and established companies through the complexities of European regulations like the 2017/745 MDR, ensuring their successful market entry and enhanced patient outcomes.

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