Validation of Mobile Medical Applications (apps)

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. 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.

Mobile apps are software programs that run on smartphones and other mobile communication devices. Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Apps can be used in several areas and for different objectives. Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance. Other apps aim to help health care professionals improve and facilitate patient care, are used in combination with Blood Establishment Computer Software (BECS), may support GCP case report forms (CRF), or are a verification tool for falsified products (GMP & GDP).

In any case such apps must be validated according best practice (e.g. ISPE GAMP 5) and related quality standards. CCS is one of the few and leading compliance consulting firms supporting the design, development, operation, and validation of mobile apps, which are used as medical devices or in any GXP related area / function.

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We will let you know more about modern and innovative apps and how to register, qualify, document, use, and operate them.


  1. US-FDA Mobile Medical Apps – Guidance for Industry – final

  2. US-FDA Guidance: BECS

  3. CCS IT and App Compliance – Validation of Apps

  4. App Development and Validation – Public Training