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.
★ KEY VIDEO TAKEAWAY★
Emergency Use Authorization for SaMD products, updates from the FDA on Digital Health initiatives, validation challenges for SaMD manufacturers, and best practices for leveraging agile method for SaMD development.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
If you’d like to watch more related videos, browse through the full list of free replays from this track of the virtual summit event: kzitem.info/door/PLkchw-at8PkO-O70hkzdbQrzc-LtFPUbM
Plus, download the slides for this presentation for free here: www.slideshare.net/greenlightguru/software-as-a-medical-device-samd-challenges-and-opportunities-for-2021-and-beyond
Are you looking for a QMS solution to help you bring safer medical devices to market faster with less risk? Take a quick tour of Greenlight Guru's Medical Device QMS software: www.greenlight.guru/quality-management-software
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Негізгі бет Ғылым және технология Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond
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