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Mobile medical apps(is it a FDA regulated device) and cybersecurity

26468 E Walker Dr, Aurora, Colorado 80016-6104
26468 E Walker Dr, Aurora, Colorado 80016-6104 Aurora, CO 80016  
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Start:   Wednesday, October 10, 2018  1:00 PM
End:   Wednesday, October 10, 2018  2:00 PM

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Event Features: Benefits Charity, Health / Wellness

Neighborhood: Avenue of the Arts



OVERVIEW This webinar will explain how to determine if your app is a medical device and if it will be subject to FDAcybersecurity requirements. The FDA approval process for mobile apps will be explained including FDA software validation requirements which are more extensive than just testing performance.
The FDA Guidance explains how they intend to apply their regulatory authority to software applications intended for mobile medical apps. They have defined what types of apps they consider a medical device. Apps that are medical devices must meet all FDA device requirements, however, FDA will not enforce their requirements on mobile apps that meet the FDA’s definition of a medical device but pose a low health risk.
• What mobile apps are medical devices?
• What areFDA regulated mobile apps?
• How to get a mobile app approved by FDA?
• Cybersecurity for mobile apps explained
Learn about FDA regulated mobile apps, along with FDA software validation requirements. Cybersecurity for mobile apps is very important. The FDA requirements for cybersecurity in the app design will also be explained in the webinar.
• Development Engineers
• Production Management
• QA/ QC personnel
• Software developers
• IT personnel
• Legal dept

For more detail please click on this below link:

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