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

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"Hear By Edwin Waldbusser is a consultant retired from industry after 30 years in management of development of medical devices (5 patents). "

The FDA requirements for cybersecurity in the app design will be explained

Description

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.

Areas Covered

•    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 will Benefit

•    Software developers
•    Production Management
•    QA/ QC personnel
•    Engineering management
•    Regulatory personnel

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Edwin Waldbusser

Edwin Waldbusser 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. 

His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

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