Mobile medical apps(is it a FDA regulated device) and cybersecurity
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
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.
WHO
WILL BENEFIT
- Development
Engineers
- Production
Management
- QA/ QC personnel
- Software
developers
- IT
personnel
- Legal dept
For more detail please click on this below
link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882

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