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.
Speakers
Cori Ragan, MS, Regulatory & Quality Systems Director, Fortrea
With over 15 years of experience in regulatory affairs, Cori Ragan has a comprehensive background working with medical device regulations across the globe. She has a Master’s degree in Software Engineering and a Bachelor’s degree in Electrical Engineering.
Her expertise extends to implantable devices, particularly within the cardiovascular and genito-urinary sectors. She is also well-versed in digital health technologies, including Software as a Medical Device (SaMD), AI/ML-based software and Clinical Decision Support Software (CDSS), showcasing a robust capability to navigate and lead in the evolving landscape of medical technology.
Message Presenter
Dr. Cheerag Shirodaria, MD, FRCP, MBA, Vice President & Cardiovascular/Metabolic Therapeutic Area Head, Fortrea; Chief Development Officer, Caristo Diagnostics
Dr. Cheerag Shirodaria is the Co-Founder and Former CEO of Caristo Diagnostics, a company specializing in AI medical imaging. He is also a practicing Cardiologist at Oxford University Hospitals. With over 20 years of experience in clinical device and diagnostics development, he brings a wealth of knowledge and expertise to the intersection of medical practice and technological innovation in healthcare. His background underscores a deep understanding of both the clinical implications and the technological advancements shaping the future of medical diagnostics.
Message PresenterWho Should Attend?
This webinar is designed for medical device developers, and anyone interested in learning more about Software as a Medical Device.
What You Will Learn
Attendees will learn about:
- The current landscape in SaMD development
- Applicable standards, guidance documents and regulations
- Regulatory pathways and key documents for market access
Xtalks Partner
Fortrea
Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.
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