The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: June 5, 2018 from 1pm to 2:30pm
Street: 9106 Seven Locks Road
Website or Map: http://www.compliancetraining…
Event Type: online, /, webinar
Organized By: Sam Miller
Latest Activity: May 22, 2018
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.
Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app design will 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 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.
Areas Covered in the Session :
Who Will Benefit:
Edwin Waldbusser retired from industry after 20 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. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs.
Edwin Waldbusser 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.