Mobile Medical App Development – Not for the Faint of Heart

Mobile Medical App Development – Not for the Faint of Heart

Overcoming the Challenges

Mobile devices and the apps that power them have quickly become a part of everyday life. The promise of “anywhere, anytime computing” is now extending to mobile medical apps, bringing a wide range of health information, device connectivity, and data to patients, caregivers, and physicians.

It’s not very difficult to create a mobile app – a number of tools have emerged which can make it pretty straightforward to develop basic functionality for a tablet or phone. A mobile medical app, on the other hand, is considerably more challenging because it involves more than just developing an app. Most medical apps must at least follow FDA or CE Guidance (for example, conformance to 21 CFR Part 820, ISO 13485, and IEC 62304) and some require full 510k regulatory approval. Therefore, mobile medical apps require a more rigorous approach to managing requirements, design, implementation, test, documentation, and overall management of the product. And even for those familiar with these processes, mobile devices present additional challenges.

As a Technical Project Manager who has been managing the development of mobile medical apps for more than four years here at Syncro Medical, I’m writing to share some advice, particularly for companies considering entering this new arena for the first time. While there are many considerations, I want to highlight three in this blog:

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