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Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond

A session by Tom Rish and Andrew Wu
Greenlight Guru and Rook Quality Systems

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About this talk

The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.

SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.

SOME OF THE TOPICS WE WILL COVER INCLUDE:  - Emergency Use Authorization for SaMD products - Updates from the FDA on Digital Health initiatives - Validation challenges for SaMD manufacturers - Best practices for leveraging agile method for SaMD development

WHO SHOULD ATTEND? - Medical Device Executives - Regulatory Affairs Professionals and Management - Quality Professionals and Management - R&D Engineers and Management

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