EU AI-enabled Medical Devices Market Authorisation Masterclass: Shape Your Use Cases and Secure a Prosperous Future for Your AI Initiatives (June 29th - June 30th, 2026)

Navigating AI in medical devices offers opportunities in regulatory understanding, strategic implementation, and competitive advantage. With a focus on the European AI Act, mastering compliance and market entry for high-risk AI systems can position companies effectively in the evolving AI-medical sector.


Dublin, April 15, 2026 (GLOBE NEWSWIRE) -- The "Masterclass: Market Authorisation of AI-enabled Medical Devices (June 29th - June 30th, 2026)" training has been added to ResearchAndMarkets.com's offering.

Keeping up with the rapidly changing regulations applicable to AI-based medical devices takes time and effort.

Many AI providers face regulatory, implementation, and investment uncertainties, particularly for advanced use cases like dynamic task specification, grounded reporting, and patient chatbots. Join this course to understand the legislative landscape and best practices, enabling you to shape your use cases and secure a prosperous future for your AI initiatives.

In the second part, participants will delve into the intricate world of the European AI Act and its impact on the medical device domain. They will gain insight into the geopolitical forces and better understand their relation with and impact on other AI legislations worldwide.

The AI Act qualifies many AI systems for medical devices as 'high-risk AI systems', mandating stringent criteria related to human oversight, safety, fundamental rights, robustness, and accessibility before entering the Union market. Our course leader will demystify the European AI Act, shedding light on its complex interplay with existing regulations governing medical devices. Participants will gain insights empowering them to implement the Act, secure their portfolios, and gain a significant competitive edge in the evolving landscape of AI-based medical devices. Cybersecurity is out of scope.

By the end of this course, participants will have gained a deeper understanding of the European AI Act's profound impact on the medical device industry, including its areas of consensus and ongoing debates. They will be equipped with practical insights to navigate the regulatory landscape.

Who Should Attend:

  • Business strategists
  • Product and service managers
  • Project managers
  • System analysts
  • Regulatory Affairs Managers
  • Compliance officers
  • Legal professionals
  • Software Engineers and Architects
  • Data Governance Specialists
  • Data Scientists
  • Biomedical engineers
  • Clinical research associates
  • Clinical informatics managers of hospitals
  • Safety Engineers
  • AI Ethicists

Key Topics Covered:

Day 1

  • Introduction to Artificial Intelligence
  • Regulation as a Strategy: AI Legislation as a Global Power Play
  • Regulatory requirements for AI-enabled medical devices
  • Best Practices for Developing AI-enabled Medical Devices
  • State-of-the-art data governance and data management

Day 2

  • EU Artificial Intelligence Act
  • Implementing the EU Artificial Intelligence Act
  • Publicly Funded Supporting Initiatives for the AI Ecosystem
  • AI Standardization landscape
  • Adaptive AI-based medical devices

CPD Hours: 12

For more information about this training visit https://www.researchandmarkets.com/r/rjl7yu

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