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Software as a Medical Device

Software as a Medical Device

Software as a medical device is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” The proper functioning of this software can make the difference between life and death for vulnerable patients suffering from chronic conditions. For this reason, it takes significantly more time to perfect this software to prevent costly mistakes in the form of life and liability.

One such example of software as a medical device is software that provides parameters to hardware concerning the flow of medication. Delivering the correct dose is essential to keeping patients safe, as well as preventing costly medical malpractice suits. Software as a medical device patents have been issued to assist with spinal and other surgeries, for example, this patent assigned to KB Medical. (

As a seasoned software developer and Intellectual Property Attorney, Mark Terry ( knows what it takes to successfully patent Software as a medical device with the USPTO. Schedule a free consultation today to discuss your options.

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