Practical Insights into Regulatory Submissions & Documentation Best Practices for SaMD, SiMD, Digital Therapeutics & CDS
Time: 3:00 pm
day: Pre-Conf Track B Afternoon
Details:
- Learning from industry peers by discussing real-world challenges and feedback encountered during regulatory submissions for various medical device categories
- Navigating essential documentation and plans by exploring the specific regulatory documentation and submission requirements for each type of medical device, including SaMD, SiMD, Digital Therapeutics, and CDS. Learn how to align these documents to regulatory standards while addressing the unique considerations of each device category
- Optimizing submissions across device categories by analyzing case studies of successful and failed submissions, focusing on the types of information critical for approval