Mobile Medical Apps (Is It an FDA Regulated Device?) and Cyber-Security

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    Speaker: Edwin Waldbusser

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    Duration: 60 Minutes
    Product Code: 50744
    Level: Advanced

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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.


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.


  • 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


Learn about mobile medical apps, including FDA software validation requirements and FDA cybersecurity requirements.


  • Development Engineers
  • Production Management
  • QA/ QC personnel
  • Software developers
  • IT personnel
  • Legal Department


Years of Experience: 30+ years

Areas of Expertise: Design Control, Risk Analysis and Software Validation of Medical Devices

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 9 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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