Comprehensive Framework for the Global Regulation and Approval of AI-Integrated Medical Devices

Abstract

Introduction: A pivotal aspect of advancing AI technology in manufacturing and healthcare lies in ensuring legal compliance and safety. To facilitate this, the development of tools and frameworks is underway, aiding manufacturers in crafting AI-based products that align with regulations and standards. Objectives: This paper focuses on providing clear, structured guidance for users involved in developing AI-based medical devices. The objectives are threefold: To clarify the expectations set forth by regulatory bodies concerning compliance for AI/ML-based software. To outline a systematic approach for implementing safety and effectiveness measures in AI-based medical devices. It addresses the absence of a unified standard by providing guidance that aligns with existing regulations as fully as possible. Methods: The study reviews existing regulations and frameworks applicable to Artificial Intelligence based medical devices in various countries. Results and Discussion: This paper provides practical tools and frameworks designed to streamline regulatory compliance processes. These resources enable manufacturers to navigate legal complexities more efficiently while minimizing legal risks and ensuring that safety and effectiveness considerations are thoroughly addressed. Conclusion: As laws and regulations continue to evolve, it is essential to create clear pathways for integrating AI technologies into medical devices. This paper provides actionable guidance that supports manufacturers in complying with current regulations, fostering a more accountable, patient-centric approach in medical decision-making and treatment. By offering structured insights and bridging the regulatory gap globally, the paper contributes to safer and more effective deployment of AI in medical devices.

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