Mobile Medical Apps ( Is It an FDA Regulated Device? ) and Cyber-Security

    /Edwin   /Waldbusserspeaker of Training Doyensinvite
    Speaker: Edwin Waldbusser
    Date: Wednesday, March 6th
    Time: 01:00 PM EST | 10:00 AM PST

    More Trainings by this Expert
    Duration: 60 Minutes
    Product Code: 50744
    Level: Advanced


This webinar will explain how to determine if your mobile apps are medical devices and if they will be subject to FDA requirements. The FDA approval process for mobile medical apps 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 cybersecurity requirements in the app design will also be explained.


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 mobile apps they consider a medical device.

Apps that are medical devices must meet all FDA software validation requirements and FDA cybersecurity 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.


  • What mobile apps are medical devices?
  • Which mobile apps are regulated by FDA?
  • How to get mobile medical apps approved by FDA
  • Cybersecurity for mobile apps explained


Learn about mobile medical apps, including FDA software validation requirements and FDA cybersecurity requirements.


  • Development Engineers
  • Production Management
  • QA/ QC personnel
  • Software developers
  • IT personnel
  • Legal Department


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

Purchase Options

Live Session

For One Participant


info icon

Corporate Live Session

Group - Max 10 Participants from one Location.(For multiple location please contact our customer support team)


info icon

Recorded Session

Get unlimited access to the link for six months. Login information will be shared 24 hours after the completion of Live webinar


Training DVD or USB Flash Drive

Free shipment within 72 Hours, from the date of webinar completion


Super Combo Offer 1

Live and Recorded webinar for $329 only!


info icon

Super Combo Offer 2

Live and Training DVD / USB Flash Drive for $499 only!


info icon
refer friend

Approved Enablers of your
Continuing Education Credits

View all CEU Approved Webinars  

View Similar Trainings

In Cross Industry Functions

Understanding and Implementing a Quality by Design Program Cross Industry Functions Wed, February 27 2019

  Steven Laurenz Time: 01:00 PM EST | 10:00 AM PST
  Carolyn Troiano Time: 01:00 PM EDT | 10:00 AM PST

Understanding and Implementing a Technology Transfer Process Cross Industry Functions Tue, March 19 2019

  Steven Laurenz Time: 01:00 PM EST | 10:00 AM PST
  Edwin Waldbusser Time: 01:00 PM EDT | 10:00 AM PST