Webinar: Navigating SaMD and SiMD 

Real-World FDA Regulatory Strategies for Medical Device Software

In this webinar, we explore the intricacies of FDA regulations for healthcare software products. Our expert speaker shares insights on navigating the FDA landscape, understanding regulatory strategies, pathways to market, and clinical data expectations. You will gain a comprehensive understanding of software functions and products within the medical device realm, whether categorized as medical devices, software as medical devices (SaMD), or software in medical devices (SiMD), all falling under FDA regulatory oversight.

We'll delve into potential pathways for bringing these software products to market and discover crucial elements for developing effective short and long-term regulatory strategies. Our expert speaker will illuminate the impact of selected regulatory pathways on algorithm training, validation, and meeting clinical data expectations.

Watch now to gain valuable insights into FDA regulations governing healthcare software products, covering strategy, pathways, and clinical data expectations.

Need help with your regulatory strategy for your medical device? 

Contact us to speak with one of our experts and tell us how we can help you achieve success.

Meet the Speaker


Connie Qiu, MEng, RAC

Senior Consultant, Regulatory Affairs, ProPharma MedTech