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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.

  • Recent FDA cleared SaMDs overview

  • Why FDA is placing such emphasis on regulating software

  • Why the IMDRF Framework and GMLP (Good Machine Learning Practice) can be critical throughout the software development lifecycle

  • How a regulatory strategy can impact software development greatly

  • What FDA is looking for from SaMD manufacturers in premarket submission

  • Upcoming FDA workshop – Evolving Role of Artificial Intelligence in Radiological Imaging

  • Q&A Session

Webinar slides can be downloaded here.

Please contact us at if you have any questions.

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