Live Webinar on Mobile Medical Apps ( Is It an FDA Regulated Device? ) and Cyber-Security
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.
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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 risk.
AREAS COVERED
- What mobile apps are medical devices?
- Which mobile apps are regulated by FDA?
- How to get mobile medical apps approved by FDA
- Cybersecurity for mobile apps explained
LEARNING OBJECTIVES
Learn about mobile medical apps, including FDA software
validation requirements and FDA cybersecurity requirements.
WHO WILL BENEFIT
- Development Engineers
- Production Management
- QA/ QC personnel
- Software developers
- IT personnel
- Legal Department
To Register (or) for more details
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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