Navigating SaMD and SiMD: Real-World FDA Regulatory Strategies for Medical Device Software

Technology > Software12/6/2023 3:00 PM

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Discover a groundbreaking webinar delving into how to navigate The Food and Drug Administration (FDA) regulations for healthcare software products, and explore regulatory strategies, pathways to market and clinical data expectations. Software products are used in a variety of healthcare applications including tracking personal health and well-being, monitoring vital signs, administering therapies, facilitating diagnoses and treatment decisions, and aiding with surgical procedures. This webinar will discuss how to determine whether a software function and/or product meets the definition of a medical device, software as a medical device (SaMD) or software in a medical device (SiMD), that is subject to The FDA regulatory oversight. Potential pathways for bringing these software products to market will be explored along with points to consider in developing short and long-term regulatory strategies. The expert speaker will also discuss how algorithm training and validation and clinical data expectations may be impacted by the selected regulatory pathway. Join this webinar and dive into The FDA regulations for healthcare software products, covering strategy, pathways and clinical data expectations.


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ProPharma is the world's largest research consulting organization. They specialize in providing bespoke solutions for the pharmaceutical and biotech industry, spanning across the full product lifecycle. With deep domain expertise and a global footprint, ProPharma offers a comprehensive suite of services including regulatory services, clinical research solutions, R&D technology, quality & compliance, pharmacovigilance, and medical information. Their innovative RCO model enables them to deliver customized solutions that meet the unique needs and challenges of their clients. ProPharma is committed to improving patient outcomes and delivering the technologies, medicines, and therapies of tomorrow.