How to Determine If Your App is a Medical Device and If It Will Be Subject to FDA Requirements?
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
Please Note:
Recorded Version will be available within 24 hours after completion of the live Webinar and will allow unlimited viewing for 3 months.
CD Version can be dispatched after 72 hours on completion of live Webinar.
Speakers
Edwin Waldbusser ,
Regulatory Consultant ,
Med Device AdvisorsEd retired from the industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as 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. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.
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. He is also owner of meddeviceadvisors which offers over 80 easy to customize medical device Quality System SOP's.
Who Should Attend
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 Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel.
