Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices
This webinar was hosted by Andrew Wu, Branch Manager | Software Consultant at Rook Quality Systems.
You will find this webinar helpful for understanding how Rook helps companies develop Software as Medical Device in time-effective and regulatory compliant manner.
This in-depth webinar will cover the most important items that companies must understand and put into practice when developing and commercializing SaMDs.
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Recent FDA cleared SaMDs overview
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Why FDA is placing such emphasis on regulating software
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Why the IMDRF Framework and GMLP (Good Machine Learning Practice) can be critical throughout the software development lifecycle
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How a regulatory strategy can impact software development greatly
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What FDA is looking for from SaMD manufacturers in premarket submission
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Upcoming FDA workshop – Evolving Role of Artificial Intelligence in Radiological Imaging
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Q&A Session
Webinar slides can be downloaded here.
Please contact us at info@rookqualitysystems.com if you have any questions.
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