Masterclass: The Essentials of Working with the FDA for the Approval of AI-based Solutions

 

HealthXL members often ask these questions in our meetings, seeking advice and best practices in their regulatory strategies in the US. They often struggle in the process. How can they think of their regulatory approach as a product and company strategy rather than an obligation?

 Join this masterclass led by Tahir Rizvi (Head of Quality Assurance and Regulatory Affairs at Caption Health) and Armen Vidian (Digital Health Venture Capitalist) to learn more about the regulatory considerations for AI-based solutions in the US. They will walk us through:  

 -Regulatory pathways: 510k, de novo, PMA. What are the differences and why should you care?
- Working with the FDA constructively. What works and what doesn’t.
- How to align your clinical evidence and regulatory strategies with the marketing/promotional strategies?
- Managing investors around the regulatory strategy