Yes, the software can be a medical device. The Food and Drug Administration (FDA) has defined medical devices as “instruments, machines, implants, in vitro reagents, and other similar or related articles, including parts or accessories,” which are “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” In other words, as long as a software product meets the definition of a medical device, it can be regulated by the FDA.
The legal compliance requirements for medical device software vary depending on the country in which the software will be used. In the United States, the Food and Drug Administration (FDA) regulates medical device software. The FDA has established various guidelines and regulations that medical device software developers must follow to ensure their products are safe and effective.
In Europe, medical device software is regulated by the European Union (EU) Medical Devices Directive (MDD). The MDD requires that medical device software meet certain safety and performance standards.
Developers of medical device software must comply with all applicable legal requirements to sell their products. Failure to comply with these requirements can result in fines, product recalls, and other legal penalties.