Mobile Medical Apps (Is It an FDA Regulated Device) and Cybersecurity

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, Aug 30, 2017
60 minutes
Product Description

FDA Software Validation and Cybersecurity Requirements for Mobile Apps that are Medical Devices

The FDA has released 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 session by expert speaker Edwin Waldbusser will explain how to determine whether your app is a medical device and whether it will be subject to FDA requirements. The session will explain the FDA approval process for a new app, including FDA software validation requirements, which are more extensive than just testing performance. Cybersecurity is important for mobile apps. The session will explain FDA requirements for cybersecurity in the app design.

Session Highlights

  • 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

Who Should Attend

  • Engineering personnel
  • QA
  • Software developers
  • Management

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Edwin Waldbusser

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 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...   More Info
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