Tibor Zechmeister is Head of Regulatory & Quality at Flinn.ai, a MedTech SaaS platform that uses AIdriven automation to simplify compliance. Over the past fifteen years he has worked in almost every regulatory role, including Notified Body lead auditor, startup founder and hands-on consultant. He has led or reviewed dozens of EU audits, helped more than fifty manufacturers secure first time or expanded clearances, and built two companies that brought novel neurodiagnostic devices from concept to market. An engineer by training, Tibor blends systems rigour with entrepreneurial speed, creating QMS architectures, PMS programs and submission dossiers that withstand global scrutiny while keeping workloads manageable. His current focus is using machine learning to remove documentation bottlenecks and accelerate evidence generation.