Masterclass: Market Authorisation of AI-enabled Medical Devices In-house Training ★★★★★

Course overview

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.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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

Please note: To benefit most from this masterclass, participants need a basic understanding of how medical devices must comply with EU MDR, EU IVDR, and FDA Regulations.