The last few years have seen a significant increase in the development of software-based products that have no direct relationship to hardware devices.
Fuelled in part by advances in artificial intelligence (AI) and machine learning (ML) technology, software as a medical device (SaMD) have significant potential to improve clinical outcomes both as an aid to diagnosis and also to refine patient risk stratification.
SaMD are still categorized as medical devices by regulatory bodies around the world, meaning that there are stringent requirements around development and validation that are required before they can be used clinically.
The expert speakers will review the key components required for a successful SaMD regulatory submission, including the latest guidance from major global regulatory bodies, using real-world examples of successful SaMD development.
Register for this webinar today to understand the latest guidance from major global regulatory bodies on making successful SaMD regulatory submissions.
Keywords: Medical Device, Regulatory, Diagnostics, Medical Device Regulation, Laboratory Technology, AI, Software, Software as a Medical Device, Other Software