ResearchBib Share Your Research, Maximize Your Social Impacts
Sign for Notice Everyday Sign up >> Login

Healthcare 2020 - Mobile Medical Apps(is it a FDA Regulated Device) and Cybersecurity

Date2020-11-10

Deadline2020-11-10

VenueOnline, USA - United States USA - United States

KeywordsHealthcare; Pharmaceutical; Medical online training

Websitehttps://www.compliance4all.com/webinar/m...503389LIVE

Topics/Call fo Papers

Overview:
This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements.
The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than just testing performance. Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app design will be explained.
Why you should 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 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.

Last modified: 2020-10-24 18:58:27