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Software as a Medical Device (SaMD) is reshaping the future of healthcare, offering intelligent, data-driven solutions to diagnose, monitor, and treat medical conditions. However, its dynamic and rapidly evolving nature poses significant Regulatory challenges across jurisdictions. From risk-based classifications to documentation requirements, global markets approach SaMD differently, making a harmonized Regulatory strategy essential for successful commercialization.
This whitepaper serves as a strategic roadmap for medical device manufacturers, Regulatory affairs professionals, and product teams seeking clarity and alignment in their global SaMD Regulatory journey. It outlines key Regulatory expectations, classification criteria, documentation mandates, and submission strategies across five major markets: the United States, European Union, Canada, Japan, and Australia. In addition, it highlights emerging trends, harmonization efforts, and compliance best practices to streamline global market entry
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