This webinar will explain how to determine if your app is a medical device and if it will be subject to FDAcybersecurity requirements. The FDA approval process for mobile apps will be explained including FDA software validation requirements which are more extensive than just testing performance.
The FDA Guidance explains how they intend to apply their regulatory authority to software applications intended for mobile medical apps. 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.
Learn about FDA regulated mobile apps, along with FDA software validation requirements. Cybersecurity for mobile apps is very important. The FDA requirements for cybersecurity in the app design will also be explained in the webinar.
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.View all trainings by this speaker