Joseph Carson
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Preparing for the PATCH Act and RTA
…Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards….
…Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards….
FDA Issues Final Guidance on Cybersecurity in Medical Devices
…cybersecurity management plans that communicate how they will identify and communicate postmarket vulnerabilities in accordance with 21 CFR 820.100. Recommends that manufacturers provide an updateability and patchability view that describes…
…cybersecurity management plans that communicate how they will identify and communicate postmarket vulnerabilities in accordance with 21 CFR 820.100. Recommends that manufacturers provide an updateability and patchability view that describes…
Precision Medicine Meets AI: Advances in Cough Monitoring
Cough is a common and, at times, problematic medical condition that is ripe for disruption. It is one of the main reasons why patients seek medical care. In Europe and…
Cough is a common and, at times, problematic medical condition that is ripe for disruption. It is one of the main reasons why patients seek medical care. In Europe and…
Carlos Chaccour, M.D., Ph.D.
The Power of AI to Enhance Clinical Trials
…new drug advancing to the next trial stage or regulatory approval is less than 14% across all therapeutic areas. These high failure rates are often attributed to the tremendous amount…
…new drug advancing to the next trial stage or regulatory approval is less than 14% across all therapeutic areas. These high failure rates are often attributed to the tremendous amount…
John Schwope
Instructional Materials: The Basis for Safety Between Users and Medical Devices
…device resulting in harm to a user or patient. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device…
…device resulting in harm to a user or patient. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device…
RenĂŠe Bailey
Flex
