Tim Hanson
Vice President - Quality Assurance & Regulatory Affairs Etiometry
Tim Hanson is Vice President of Quality Assurance and Regulatory Affairs at Etiometry, where he leads global regulatory strategy and quality systems for AI-enabled Software as a Medical Device (SaMD). With over 20 years of experience in highly regulated healthcare environments, Tim has successfully guided medical device and digital health products through U.S. (FDA 510(k)), EU/UK, and Canadian market authorizations while building scalable, audit-ready quality management systems.
He specializes in aligning modern software development practices—including agentic AI, adaptive algorithms, and cybersecurity frameworks—with evolving global regulatory expectations. Tim works closely with engineering, clinical, and product teams to translate regulatory strategy into practical, lifecycle-focused execution that accelerates review timelines and reduces compliance risk.
Seminars
- Practical walkthrough of a submission journey including pre-sub meetings, review questions, and lessons learned, followed by discussion
- What regulators expect in modern software and AI submissions
- Structuring documentation for clarity, traceability, and review efficiency
- Managing pre-submission interactions and mid-review information requests
- Lessons learned from successful and delayed software submissions
