10 Mar 2021Ended

The Regulatory Landscape of Software as a Medical Device


Estimated Turnout

upto 100
Based on previous editions


Mar 2021


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So much of the medical world is about data, and as healthcare data continues to play an increasing role in the “big data” landscape, the .. Read more challenge is figuring out how to use it properly within the healthcare ecosystem. A new class of medical software known as Software as a Medical Device (SaMD) is offering innovative ways to capture, optimize and analyze healthcare data with the goal of improving health by utilizing analytics to manage and optimize health outcomes. However, this rich field of technology is evolving more quickly than regulators can keep up. The challenge is when a software is designated as SaMD, a string of regulatory requirements come into play, creating a maze of potential pathways and product development implications. In this webinar, the panelists will define what is considered a SaMD and explore key strategies to bring it to market successfully through regulatory strategy, clinical impact and considerations for patient engagement and participation. He previously served as the Vice President of Regulatory at Premier and has been in leadership positions at both CROs and sponsor companies. Our hand-curated daily news feed and active message forums will keep you informed.

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