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

Speaker

Instructor: Edwin Waldbusser
Product ID: 705432

Location
  • Duration: 60 Min
This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.
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Why Should You Attend:

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.

Areas Covered in the Webinar:

  • 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 Will Benefit:

  • Engineering Manager
  • Regulatory Personnel
  • Development Engineers
  • Production Management
  • QA/QC Personnel
  • Software Developers
  • Usability Engineers
  • Risk Managers
  • Design Engineering Managers
Instructor Profile:
Edwin Waldbusser

Edwin Waldbusser
Regulatory Consultant, Med Device Advisors

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 Reuters Expert Witness network.

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