Скачать или смотреть Webinar: Meeting FDA Requirements for BLE Mobile Medical Apps | Orthogonal

This video is a recording of a live webinar organized by Orthogonal and MedSec that took place on September 20th, 2023. This event featured a discussion on the FDA requirements for mobile medical apps connected to Bluetooth-enabled medical devices, and how to meet those requirements. You can read the summary of the webinar on our blog: https://orthogonal.io/insights/blueto...

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Despite a lack of specific guidance and constantly evolving standards, mobile medical apps and their companion Bluetooth Low Energy (BLE)-enabled medical devices consistently make it through the FDA clearance process. Manufacturers obtain clearance for their apps by meeting the FDA’s standards for mobile platform compatibility, cybersecurity and other domains. What are those standards, how do you fulfill them, and how do you maintain device safety and effectiveness when mobile platforms and cybersecurity threats inevitably change?

Orthogonal and MedSec held a webinar on understanding FDA requirements for BLE mobile medical apps. Expert speakers from both companies shared insights and experiences gained from preparing mobile medical apps connected to BLE medical devices for FDA submission.

This recording includes the 50-minute core content presentation, followed by a speaker Q&A.

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Expert speakers on this webinar:
*Bernhard Kappe, CEO and Founder, Orthogonal
*Buddy Smith, Director of Technical Consulting, MedSec
*Randy Horton, Chief Solutions Officer, Orthogonal