Mobile / web / cloud app

The phone, browser and server software the device talks to, developed under IEC 62304 alongside the hardware so the two are verified together.

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When a mobile, web or cloud app is the right step

When a device needs an app for patients, a dashboard for clinicians or a cloud service that stores and syncs data. Its safety class and its data rules follow from what it does.

Give a device a companion app
A phone app that pairs with a device, shows the readings and guides the patient.
Give clinicians a dashboard
A web dashboard where clinicians review patients, trends and alerts from connected devices.
Store patient data safely
Secure sync and storage of health data, with the access controls and records that data protection law expects.

What you bring, and what you get back

You bring

What the app must do, and for whom
The device and its data protocol
Who may see which data
Where the users and the data will be
Brand guidelines, if you have them

You get back

Software requirements and architecture
The apps and cloud services, versioned
Test records
Deployment and support plan
Data protection and security documentation

What the app does decides how it is regulated

An app that only records and displays data carries less regulatory weight than one that analyses data to support a diagnosis or a treatment. Software with a medical purpose can be a medical device on its own, and then the software life cycle of IEC 62304 applies. Health software that is not a device still has product safety expectations under IEC 82304-1. Decide the intended use first, because it sets the class, the process and the evidence.

How app and cloud development works

Step 1
Define the app
What it does, for whom, and its safety class as medical software.
Step 2
Design the system
The data flows, the hosting and where patient data lives.
Step 3
Build in iterations
Short cycles, each tested and reviewed.
Step 4
Release and run
Deployment, monitoring and a plan for updates.

Questions clients ask

Is our app a medical device?

It depends on its intended use. An app that analyses data to diagnose, monitor or treat is likely to be regulated as a medical device. One that only stores or displays data may not be. The class and route tool helps you check.

Where will patient data be stored?

Where the law and your users require. In India, the Digital Personal Data Protection Act, 2023 sets duties on how personal data is collected, used and protected. Other markets have their own rules, so choose the hosting per market.

Do iOS and Android need separate apps?

They can share one code base or be built natively. The choice depends on what the app needs from the phone, such as Bluetooth in the background, and on how it will be tested and maintained.

How are updates handled after launch?

Each update is planned, tested and released under configuration control, and assessed for its effect on safety. A medical app also needs a record of which version each user runs.