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

Compliance Key INC - FDA Compliance Training

                                         Edwin Waldbusser
Ed is Keynote Speaker at Compliance key Inc. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. 
 Webinar Id: LSHCMEW004
 10:00 AM PT | 01:00 PM ET
 10/24/2017
 Duration 60 mins 
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 should you attend this webinar?
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 can Benefit:
  • Target audience, role/designation.
  • Development Engineers
  • Production Management
  • QA/QC personnel
  • Software developers
  • IT personnel

Compliance Key INC
717-208-8666
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Location: United States

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