Training Doyens

There is hardly any aspect of the world today that is untouched by technology. And, in the wake of technology strengthening its presence in every industry, digital health has emerged as a buzzword in healthcare. Digital health can be defined as the combination of digital technologies and healthcare which aims at enhancing the healthcare quality and delivery. Healthcare industry is experimenting with new technologies to refine the procedures and get desired results in a short span of time. Recently, clinical trials have experienced a much desired transformation owing to digital technologies. Not only there have been innovations, but also elimination of many traditional barriers and constraints. With new digital platforms making their way into healthcare, the efficiency and productivity of clinical trials encountered a great surge, resulting in increased patient engagement, new outcomes and reduced patient withdrawal. Let’s have a look at the most prominent digital trends that a...

OVERVIEW 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. FDA cybersecurity requirements WHY SHOULD YOU ATTEND 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 ri...