Training Doyens

OVERVIEW This webinar will explain how to determine if your mobile apps are medical devices and if they will be subject to FDA requirements. The FDA approval process for mobile medical apps will be explained including FDA software validation requirements which are more extensive than just testing performance. Cybersecurity is very important for mobile apps. The FDA cybersecurity requirements in the app design will also be explained. FDA cybersecurity requirements WHY SHOULD YOU ATTEND The FDA has released a Guidance explaining how they intend to apply their regulatory authority to software applications intended for use on mobile platforms. They have defined what types of mobile apps they consider a medical device. Apps that are medical devices must meet all FDA software validation requirements and FDA cybersecurity 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 ri...

OVERVIEW This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA cybersecurity requirements . The FDA approval process for mobile apps will be explained including FDA software validation requirements which are more extensive than just testing performance. WHY SHOULD YOU ATTEND 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. AREAS COVERED 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 LEARNING OBJECTIVES Learn about FDA regul...