Software Medical Devices - United-Digitals


Evaluation and improvement

There are many health and wellness applications available for download via Apple or Google Play stores which take advantage of modern mobile technologies. Sadly though, there is a growing reluctance to use them over a long period of time by patients and HCPs. This could possibly be due to lack of trust or disappointment concerning quality, usability, validity and efficacy of these products. A registered, fully approved and validated software (only with accepted Software Medical Device (SMD) status and CE marking).

It is developed and maintained by qualified vendors, has the opportunity to be quickly adopted and utilised, therefore, providing long term benefits beyond the use of prescribed drugs, for both patients and physicians. All software which has a medical, wellness management or health related purpose or function (including software proposed for use in clinical trials), is usually defined as “Medical Software” and must be assessed to determine whether it is a Software Medical Device.

EU regulations

SMD Compliance

Software which is not considered as “Medical Software” includes software for archive, storage, simple search, websites or applications that only deliver information to the intended audience about products or services, inventory supply and management, disease education, or marketing.

Definition of standalone Software Medical Device (SMD) provided in EU MD Directive 93 / 42 and European Commission Guidance MEDDEV 
2.1 / 6 (Jan 2012) includes Software (computer programmes), which performs actions on data (e.g. calculations, enhancements, interpretations), for the benefit of individual patients and is intended by its manufacturer to be used for a “medical purpose”, which includes diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability.


Digital solutions that help.

The World is saturated with web and mobile applications that make your life easier or allow you to do anything you want. We can build an app to support and help you reach your goals.

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Powerful and proven communication channel.

Accessible, responsive websites that contain static and interactive content to attract and educate users all with compliance in mind.

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augmented reality

Benefits of Augmented Reality in software medical devices

By simple scanning a marker, which in specific cases can be a skin lesion for example, AR technology matches its recognised image with a corresponding diagnosis via a preprogrammed cloud database, which can support physician or even allows for an ordinary patient to self-diagnose themselves.

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virtual reality

Virtual Reality as part of diagnostic and therapeutic processes

VR provides a new reality, either through life or prerecorded footage, animations first person therapeutic gaming, and complete immersion of user in another real or fake world. By using VR technology patients and physicians can interact with non accessible structures and experience an unique sensations. VR Software Medical Devices are diagnostic and therapeutic tools and are used in treatment of Post-Traumatic Stress Disorder, Phobias or Pain Management.

United-Digitals is currently developing our own VR SMD for diagnosis and therapy of children with Dyslexia (Dysgraphia). It is based on stationary VR solutions, which allow for motion and touch capture. 

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