OCT 10

Mobile medical apps(is it a FDA regulated device) and cybersecurity


All other Events(no CPF)




  10 Oct 2018 through 10 Oct 2018


  Online Event

Website URL:


Sponsoring organization:

  Training Doyens


  Medicine & Health > Pharmaceutical/Medicinal

Event description:

OVERVIEW This webinar will explain how to determine if your app is a medical device and if it will be subject to FDAcybersecurity requirements. The FDA approval process for mobile apps will be explained including FDA software validation requirements which are more extensive than just testing performance. WHY SHOULD YOU ATTEND The FDA Guidance explains how they intend to apply their regulatory authority to software applications intended for mobile medical apps. 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 • What mobile apps are medical devices? • What areFDA regulated mobile apps? • How to get a mobile app approved by FDA? • Cybersecurity for mobile apps explained LEARNING OBJECTIVES Learn about FDA regulated mobile apps, along with FDA software validation requirements. Cybersecurity for mobile apps is very important. The FDA requirements for cybersecurity in the app design will also be explained in the webinar. WHO WILL BENEFIT • Development Engineers • Production Management • QA/ QC personnel • Software developers • IT personnel • Legal dept For more detail please click on this below link: https://bit.ly/2MnI4vr Email: support@trainingdoyens.com Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882

Posting date:

19 September 2018
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