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

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"Hear By Charles H Paul has been a regulatory and management consultant and an Instructional Technologist for 30 years"

Cybersecurity is very important for moblile apps. The FDA requirements for cybersecurity in the app design will be explained

Description

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. 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 software validation requirements which are more extensive than just testing performance. ybersecurity is very important for moblile apps. The FDA requirements for cybersecurity in the app design will be explained

Why should you attend :

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 moblile apps. The FDA requirements for cybersecurity in the app design will be explained

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

Who will Benefit

--     Software developers
--     Production Management
--     QA/ QC personnel
--     Engineering management
--     Regulatory personne

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Charles H Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues. 

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military. 

He has dedicated his entire professional career explaining the benefits of performance-based training

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