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Futuristic picture of a human head and DNA strand, representing DEKRA Artificial Intelligence Services for Medical Devices in Healthcare
Artificial Intelligence Services for Medical Devices

Empowering the Future of Healthcare with Safe, Secure and Compliant AI

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Unlocking the Benefits of AI in Healthcare

As Artificial Intelligence (AI) continues to transform healthcare, it enhances medical devices by improving diagnostic accuracy, enabling faster clinical decision-making, and increasing personalization in patient care. AI elevates device’s performance by optimizing data analysis, automating complex tasks, and ensuring consistent outcomes.
Incorporating an AI safety component in a medical device expands the regulatory landscape of medical devices by requiring compliance with the EU AI Act and other AI regulations, which demands requirements for transparency, trustworthiness, and ethical standards into every phase of product development. This ensures not only compliance but also reinforces market confidence and accelerates access to global markets.
Ensuring the safety, performance, and compliance of AI-enabled medical technologies is essential to protect patients and maintain trust in healthcare systems. With decades of experience in medical device certification and regulatory compliance, DEKRA is your trusted partner for navigating the evolving landscape of AI and bringing trustworthy, innovative solutions to the market.

Our Services

Trainings
  • Professional training services open to the public, aimed at empowering organizations in the successful deployment of AI technologies. These programs provide participants with the essential knowledge and expertise to integrate AI effectively, and in compliance with applicable standards and regulations.
  • Performance and Testing Processes for AI-enabled medical devices.
  • Testing and Controls for AI Risks on AI-enabled medical devices.
  • AI Act and High-Risk AI Systems Training.
Testings
Accelerate Medical Innovation with Trusted AI Services
Deliver smart, secure, and compliant AI-driven technologies for healthcare.
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Safe and Compliant Medical AI with DEKRA

Our in-depth expertise in medical device safety, combined with our expanding capabilities in AI assessment, cybersecurity, and regulatory compliance, position DEKRA as the right partner to support your organization through the complexities of AI integration.
  • Pioneers in AI Assessment: Active contributors to international standardization technical committees and policy development for trustworthy AI.
  • Global Reach with Local Support: With experts across Europe, APAC, and the Americas, we provide support worldwide.