mHealth Apps | Tablet iOS Android
*Mobile apps are software programs that run on smartphones and other mobile communication devices such as tablets. They can also be hardware accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software.
Mobile medical apps are medical devices that are mobile apps, which by the developer’s use intent meet the definition of a medical device, can be an accessory to a regulated medical device or transform a mobile device into a regulated medical device.
Consumers, caregivers, and health care professionals can use mobile medical apps and mobile apps to manage their own health and wellness, and or monitor and oversee patient care.
If your mobile or cloud based app falls under the FDA or EU guidance, Do you know if it’s regulated or not?
The CRO Group can determine if your app may need a 510(k) or Notified Body review.