In an era where artificial intelligence is rapidly transforming healthcare, the convergence of the EU AI Act, EU Medical Device Regulation (MDR), and International standards like ISO/IEC 42001 poses both challenges and opportunities for medical device manufacturers. This workshop offers a unique opportunity for regulatory, quality, and technical professionals to gain a comprehensive understanding of this evolving regulatory landscape. By integrating the EU AI Act, EU MDR, along with ISO/IEC 42001, participants will learn how to ensure compliance while driving innovation.
This workshop will delve into the differences and similarities between these regulations, providing attendees with a comprehensive understanding of their implications for product development, risk management, and compliance. Through interactive discussions participants will learn how to effectively integrate these standards into their Quality Management Systems (QMS) and regulatory strategies.
Key topics will include: Comparing and contrasting the core requirements of the EU AI Act, EU MDR, and AI 42001. Identifying areas of overlap and potential conflicts between the regulations. Developing strategies to address the challenges and opportunities arising from the convergence of these standards. By attending this workshop, participants will gain valuable insights into the regulatory challenges and opportunities surrounding AI in medical devices. They will be equipped with the knowledge and tools to navigate this complex landscape and ensure compliance with the latest regulations.
LEARNING OBJECTIVES Upon completion of this workshop, participants should be able to: Compare and contrast the key requirements of the EU AI Act and EU MDR. Identify areas of overlap and potential conflicts between the regulations, and strategies for using existing standards/regulations. Develop strategies to address the challenges and opportunities arising from the convergence of these standards.
Learning Objectives:
Compare and contrast the key requirements of the EU AI Act, EU MDR, ISO 13485 and ISO/IEC 42001.
Identify areas of overlap and potential conflicts between global regulations.
Develop strategies to address the challenges and opportunities arising from the convergence of multiple standards in risk management, clinical evaluation, and performance testing for AI enabled medical devices.
Bring back cross-functional critical thinking techniques, such as phase gate reviews for AI to organizations to make more informed decisions
Develop risk-based thinking for AI development and deployment in a healthcare setting
