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
Webinar slides can be downloaded here.
Please contact us at firstname.lastname@example.org if you have any questions.