AI/ML and SaMD Medical Devices: New and Unique Challenges in Getting to Market

In the rapidly evolving field of digital health, understanding the regulatory and clinical requirements for Software as a Medical Device (SaMD) products is crucial for success. This must-attend webinar will provide you with the essential knowledge and tools to navigate this evolving, complex FDA marketing authorization process. Our industry experts will share their insights and practical tips to help you understand what is unique and different about SaMD products from a regulatory requirement perspective so you can bring your innovative SaMD to market efficiently. Whether you’re a startup developing your first medical device or an established company exploring this new space, this webinar will equip you with the strategies needed to overcome common challenges and stay ahead in the competitive digital health landscape. Don’t miss this opportunity to gain a comprehensive understanding of the regulatory pathways, device development, evaluation strategies/requirements, and unique cybersecurity and data privacy concerns critical to getting your SaMD on the market.

Key Learning Points:

1. FDA’s AI/ML Action Plan: Understanding FDA’s Thinking About SaMD
   – Understand that the regulatory requirements for all medical devices also apply to SaMDs
   – Gain a comprehensive overview of the FDA’s thinking about the unique regulatory aspects concerning SaMD
2. The Good Machine Learning Practices Model
   – Discover the importance of clinical evidence in the approval process
   -Learn how to design and conduct clinical studies for SaMD
   -Understand the types of data and documentation needed to demonstrate safety and efficacy
3. Challenges Posed by the Unique Data Collection Process Throughout the SaMD Product Lifecycle
   – Explore best practices for ensuring the cybersecurity of your SaMD
   – Learn about the FDA’s expectations for data privacy and protection
   – Understand how to implement robust security measures to safeguard patient information

*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com. 

NAMSA uses a third-party provider, GoToWebinar, to host NAMSA webinars. For information related to GoToWebinar’s privacy policy and utilization of information, please contact GoToWebinar directly.