When: |
10 Oct through 10 Oct 2018 | |
Where: |
Online Event | United States | |
Website URL: |
https://bit.ly/2ML096X | |
Sponsoring organization: |
Training Doyens | |
Categories: |
Medicine & Health - Pharmaceutical / Medicinal |
Keywords:
Event description:
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.
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 regulated mobile apps, along ...
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Posting date:
19 September 2018 | 151 views
Placement:
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