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

Product Id : FDA51
Instructor : Edwin Waldbusser
Oct 25, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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FDA Software Validation and Cyber-security Requirements for Mobile Apps that are Medical Devices

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.Mobile applications (apps) can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it. These tools are being adopted almost as quickly as they can be developed.

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.

The session will explain FDA requirements for cyber-security in the app design. This vulnerability increases as medical devices are increasingly connected to the Internet, hospital networks, and to other medical devices. also increases the risks of potential cyber-security threats, these same features also improve health care and increase the ability of health care providers to treat patients. There seems to be no escaping the ubiquitous onslaught of wearable sensors designed to monitor and measure all kinds of physical parameters. Often, these devices have Bluetooth connections to your smartphone to allow for greater processing and storage of data.  Determining when these products are subject, as medical devices, to regulation by the U.S. Food and Drug Administration (FDA) is a very hot topic, both at the agency and in the industry.

Session Highlights:

  • What mobile apps are medical devices?
  • What mobile apps will be Planned by FDA?
  • What mobile apps will be regulated by FDA?
  • How to get a mobile app approved by FDA?
  • Does the FDA Regulates mobile devices and mobile APP Stores?
  • Does the guidance’s apply to electronic health record?
  • Cyber-security for medical devices and hospital network
  • Cyber security for mobile apps

Who Should Attend:

  • Engineering personnel
  • Quality Professionals
  • Software developers
  • Management
Speaker Profile:

Edwin Waldbusser is a Regulatory Consultant at Medical Device Advisors. He is holder of BSc. Mechanical Engineering and Master in Business Administration.

After more than 20 year of work and retirement from management of medical devices development (5 patents), Mr. Waldbusser is now a highly experienced consultant. He has been a consultant in the fields of risk analysis, software validation and design control for 8 years now.

Mr. Waldbusser is a Lloyds of London ISO 9000 Lead Auditor. He is also a board member of Thomson Reuter Expert Witness network.

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