Search
  • Andrew Wu

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 info@rookqualitysystems.com if you have any questions.

Sponsored by

#SaMD #FDA #IMDRF #GMLP #IEC62304

172 views
Archive
Please reload

Search By Tags

© 2020 Rook Quality Systems. All Rights Reserved. 

1155 Mount Vernon Hwy, Suite 800, Dunwoody, GA 30338