Leon Doorn

Chair Medical Device / AI Working Group at NEN (Dutch Standardisation Institute)

Speaker

Leon J. Doorn is the Founder and Director of MedQAIR B.V., an Amsterdam-based consultancy specialising in quality, regulatory affairs, and information security for SaMD, SaIVD and AI-enabled healthcare software. He holds a Master of Science in Health Sciences from the Vrije Universiteit Amsterdam and brings over 15 years of experience in medical device regulation, with deep specialisation in Software as a Medical Device (SaMD) and AI-driven clinical applications.

Before founding MedQAIR, Leon served as Head of Regulatory Compliance at Aidence B.V., an AI medical imaging company acquired by RadNet Inc. (DeepHealth), where he built the compliance function from inception, secured CE marking for the AI product portfolio, and led the company's first FDA 510(k) submission.

Leon is an Expert Member of the ISO/IEC SC 42 and CEN-CENELEC JTC 21 committees, contributing to key international AI standards including ISO/IEC 42001, ISO/IEC 5338, and IEC 63450. He chairs the Dutch national AI and Medical Device Expert Group at NEN, where he has led consultation responses on the EU AI Act and the European Health Data Space Regulation. A certified Data Protection Officer and published author in the Journal of Medical Device Regulations, Leon regularly speaks at international conferences on AI regulation, data protection, and the evolving compliance landscape for digital health.