With a few clicks, you can check to see whether your software is a medical product or not.
1 Is the Software integral part of medical device, eg. a control software for a fluoroscope?
In our guide on "Medical Software and Apps" we show when an app is a medical product and answer further questions concerning legal frameworks and best practices.
*software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
White Paper "Medical Apps"
Medical Apps — Intelligent Assistants or Complex Medical Products? We show when an app is a medical product and which legislation then has to be observed.
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Medical Software & Apps
The digitalization of the health care system is progressing. Wearables track the fitness of their users and medical apps can help patients to cope with their illnesses and improve therapies. For the doctors, medical apps can facilitate diagnosis and treatment.
As medical software, medical apps may be subject to the Medical Device Directive (MDD) or the Medical Device Regulation (MDR); however, they don’t have to be.
Learn more about medical software and medical apps. Trendsetting e-health solutions, medical software, healthcare apps and health marketing can also transform your business. We will be pleased to advise you.