In this free webinar, learn about the current landscape in software as a medical device (SaMD) development. Attendees will learn about the applicable standards, guidance documents and regulations. The featured speakers will discuss regulatory pathways and key documents for market access.

TORONTO, Sept. 11, 2024 /PRNewswire-PRWeb/ — 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.

Join Cori Ragan, MS, Regulatory & Quality Systems Director, Fortrea; and Dr. Cheerag Shirodaria, MD, FRCP, MBA, Vice President & Cardiovascular/Metabolic Therapeutic Area Head, Fortrea; Chief Development Officer, Caristo Diagnostics, for the live webinar on Monday, September 30, 2024, at 11am EDT (4pm BST/UK).

For more information, or to register for this event, visit Creating Software as a Medical Device (SaMD) Technology in the Ever Changing Regulatory Environment.

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