Online Masterclass Course: Market Authorisation Of AI-Enabled Medical Devices (Nov 18Th-19Th, 2025)

(MENAFN- GlobeNewsWire - Nasdaq) Market opportunities include mastering AI regulations, particularly the European AI Act, to gain competitive advantages in AI medical devices. By understanding compliance and mitigating regulatory risks, businesses can secure portfolios and enhance product development, ultimately navigating AI legislation effectively.

Dublin, Sept. 24, 2025 (GLOBE NEWSWIRE) -- The "Masterclass: Market Authorisation of AI-enabled Medical Devices Training Course (Nov 18th-19th, 2025)" has been added to ResearchAndMarkets's offering.

Join this course to gain a solid understanding of the legislative landscape, enabling you to shape your use cases and secure a prosperous future for your AI initiatives.

It is challenging to keep up with the rapidly changing regulations applicable to AI-based medical devices. Many AI providers face regulatory, implementation, and investment uncertainties, particularly for advanced use cases like dynamic task specification, grounded reporting, and patient chatbots.

This course will also 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. The course leader will demystify the European AI Act, shedding light on its complex interplay with existing medical device regulations. 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.

By the end of this course, participants will emerge: enlightened about the profound impact of the European AI Act on the medical device industry, including its areas of consensus and ongoing debates, and be equipped with practical insights to navigate the regulatory landscape.

Benefits of attending:

• Get up to speed with current regulations and standards on AI-based medical devices and data
• Learn best practices for the development and regulatory submissions of AI-based medical devices
• Understand the interplay between medical devices and AI legislation
• Consider the impact on medical device use cases
• Learn how to convey in plain language how your company can comply with and safeguard its product roadmaps
• Identify the avenues available to mitigate the regulatory and investment uncertainties

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:

Regulatory requirements for AI-enabled medical devices

• Overview legislation and guidance specific to AI-based medical devices
  • Regulatory initiatives (AU, CA, CN, EU, IMDRF, UK, US.)
  • Notified body initiatives
  • Future perspectives
• Lessons learned from regulatory submissions of AI-based medical devices
  • Describing your application
  • Clinical considerations
  • Data governance considerations
  • Post-market considerations
  • Common pitfalls

EU artificial intelligence act

• Introduction to the proposed European AI Act
• Timeline
• Scope

EU artificial intelligence act provider obligations

• Joint Conformity Assessment
• Standards
• Risk Management
• Fundamental Rights
• Data Governance
• Logging
• Transparency
• Human Oversight
• Accuracy and Robustness
• Cybersecurity
• Usability and Accessibility
• Environmental Sustainability
• Document Retention

EU artificial intelligence act

• Deployer obligations
• Notified body obligations
• Authorized representative obligations
• AIA governance
• AIA Timelines - detailed
  • AIA implementing measures & standards
  • AIA review
  • AIA vs MDR/IVDR transition
• Penalties
• How to prepare for the AI Act as a medical device manufacturer?

Adaptive AI-enabled medical devices

• Role of machine-learning enabled medical devices (MLMD) in healthcare
• Learning during clinical use
• Change considerations
• Predetermined change control plan
• Significant changes to adaptive AI-based medical devices

General purpose artificial intelligence

• Compliant conversations: Large language models for medical devices
• Generalist medical AI systems
• GPAI model provider obligations following the EU AI Act
• GPAI models throughout the value chain
• Creating trust
• Finding answers to your challenges
  • Regulatory sandboxes
  • EU Testing and experimentation facilities

Standardisation landscape

• Overview of standards for AI-based medical devices
• Overview of horizontal standards with their impact on medical devices
• Overview of standards in support of the AI Act
• Trustworthiness framework
• Interplay between horizontal and vertical standardization landscape

Geopolitical considerations of AI landscape

For more information about this training visit

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