MedQAIR

Jul 8, 2026

AI/ML-Enabled Medical Devices

Leon Doorn

Our Regulatory Experts help you navigate through the complex and fast-evolving AI and Medical Device regulatory framework.

What Do We Offer?

The regulatory field around Artificial Intelligence (AI) is rapidly evolving globally. Artificial Intelligence offers excellent opportunities to enhance diagnostic accuracy, improve treatment, and increase efficiency and consistency within the healthcare sector.

Regulators are adopting different approaches to ensure the safe and responsible use of Artificial Intelligence. The European Union has enacted the AI Act (2024/2689), the first regulation to govern Artificial Intelligence. Other countries are adopting similar strategies, though with a more targeted focus. While the EU takes a broad, horizontal approach to regulating AI, nations like the United States are implementing specific measures to ensure the safety of AI-enabled medical devices and software with artificial intelligence.

Irrespective of the chosen approach, standards are already in place and may apply to the development of AI, and AI used within medical devices. Such standards support quality management system practices (per ISO 13485, IEC 62304), data management practices (per ISO/IEC 5259 standards), AI change management, AI risk management (BS/AAMI 34971), AI lifecycle management (per IEC 62304).

At MedQAIR, our co-founder, Leon Doorn, played a key role in one of the first medical device companies to integrate Artificial Intelligence for detecting, classifying, and segmenting abnormalities. His experience spans regulatory landscapes in the European Union, the United States, and Canada. As an expert in standardisation committees, he was involved in the early development of AI standards (BS/AAMI, SC 42, JTC 21, and TC 62). Through the standardization body, he and the Dutch committee actively contributed to shaping the European AI Act and the European Health Data Space Regulation (EHDS) by providing input to the European Commission.

As compliance partners for AI medical devices, we ensure that your AI systems meet global regulatory standards, mitigating risks and facilitating compliance across key markets.

Services

  • AI medical device regulation consultation
  • AI Management System implementation
  • Assessment of compliance against the European AI Act (gap assessment)
  • QMS documentation implementation & upgrade
  • Data management and governance support
  • Cybersecurity support
  • AI risk assessment support
  • Training on the regulatory framework and standards
  • Technical Documentation writing
  • Design controls and risk management for AI/ML systems per 21 CFR Part 820
  • Clinical study protocol review
  • FDA Pre-Sub and Breakthrough Device Designation submissions
  • FDA submissions (510(k), PMA)

Relevant Resources - EU

Relevant Resources - EU

Relevant Resources - US

Relevant Resources - Others

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