Case Study: Turning Your FDA Relationship into a Core Competency to Streamline Review Processes

• 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

Speakers:

Tim Hanson

Vice President - Quality Assurance & Regulatory Affairs

Etiometry