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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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Enforcement Policy - Digital Health Devices For Treating Psychiatric Disorders During the COVID-19

Link to the Policy Document: https://www.fda.gov/media/136939/download The FDA recently put out a new enforcement policy for digital health devices treating psychiatric disorders during the COVID-19 Public Health Emergency. Release of the policy is intended to help expand the availability of digital health therapeutic devices for psychiatric disorders to facilitate consumer and patient use while reducing user and healthcare provider contact and potential exposure to COVID-19. Please note that digital health devices that are intended to be solely or primarily relied upon by the health care professional or patient to make a clinical diagnosis or treatment decision are not within the scope of t

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 greatl

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