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

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements. Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app usage will be explained.

Edwin Waldbusser
Instructor:
Edwin Waldbusser
Date:
Tuesday, February 25, 2020
Time:
10:00 AM PST | 01:00 PM EST
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 502938

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
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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.

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 software validation requirements which are more extensive than just testing performance.

Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app usage will be explained.

Areas Covered in the Session:

  • What mobile apps are medical devices
  • What mobile apps will be regulated by FDA
  • How to get a mobile app approved by FDA
  • Cybersecurity for mobile apps explained

Who Will Benefit:
  • Development Engineers
  • Production Management
  • QA/ QC Personnel
  • Software Developers
  • IT Personnel
  • Legal Dept


Speaker Profile
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.


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