Mobile Medical Apps (is it regulated by FDA) & Cyber-Security
- Speaker:Edwin Waldbusser
- Product Code:GRC-90461
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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.
Cyber-security is very important for mobile apps. The FDA requirements for cyber-security in the app design will be explained
Why you must 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.
Cyber-security is very important for mobile apps. The FDA requirements for cyber-security in the app usage will be explained.
- What mobile apps are medical devices
- What mobile apps will be regulated by FDA
- How to get a mobile app approved by FDA
- Cyber-security for mobile apps explained
Who will benefit:
- Medical Device Industry
- Development Engineers
- Production Management
- QA/ QC personnel
- Software developers
- IT personnel
- Legal dept
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting 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.