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.

*mHealth (also written as m-health or mobile health) is a term used for the practice of medical and public health, supported by mobile devices. The term is most commonly used in reference to using mobile communication devices, such as mobile phones and PDAs, for health services and information.  Mobile applications (apps) can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it, and, allow their health care providers and caregivers to participate as well. According to the FDA and, “these tools are being adopted almost as quickly as they can be developed. According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications.”