Founder | ADHOCON UG
EN ISO 17024 Certified Expert for AI in Healthcare, Medical Devices, and IVDs
Keynote Speaker
Rudolf Wagner is a Quality and Regulatory Affairs Expert with more than 15 years of experience in the pharmaceutical, medical device, and Digital Health sectors. He holds EN ISO 17024 certifications as an Expert for AI in Healthcare and as an Expert for Medical Devices and IVDs across all classes.
He is the Founder and Managing Director of ADHOCON, an ISO 13485:2016-certified Contract Legal Manufacturer and Regulatory AI Agency. ADHOCON supports clients in bringing medical devices and AI-based Software as a Medical Device (SaMD) to market in 132 countries. Its services include regulatory-grade AI tools such as automated audit companions, dossier drafting systems, and quality management system improvers. These tools are implemented on-premise for data security, used by notified bodies, and applied to simulate audits and design file reviews.
Before establishing ADHOCON, Rudolf was Global Director and Head of Quality & Regulatory Affairs at Huma Therapeutics. In that role, he oversaw the EU MDR Class IIb and US FDA 510(k) certification of an AI-powered remote patient monitoring platform, completed in 307 days. Earlier in his career, he held senior regulatory and quality positions at Getinge Group, Merck, Reckitt Benckiser, Warner Chilcott, and Abbott, managing international submissions, quality systems, and product launches across all device classes and major markets.
Rudolf contributes to EU AI Office Working Groups and IEEE activities related to AI in public health. He has been involved in the registration of more than 200,000 products worldwide, the design of lean regulatory processes that integrate AI into existing workflows, and regulatory due diligence for mergers and acquisitions in life sciences. His work combines regulatory knowledge, AI application, and legal manufacturer responsibility, with a focus on compliance and timely market access.
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