Tag: medical devices
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Medical software development – Finite state machines
Food and Drug Administration (FDA) regulates significant portion of medically relevant devices and drugs but it is probably not as well known that they also regulate the software that is used to power many of the studies. There are significant guidelines from FDA that are used for manufacturers of software that regulate medical devices. The…
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FDA Unique device identification rule
FDA has been working to release a rule that will require that each medical device be uniquely identified by an identification number and bar code. This will enable each device to be targeted in case there are any issues at a later point. This requires that as the medical devices are made, they need to…
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Small convenient medical devices
The thinking is that sophisticated devices are needed for some biomarker studies and medicine. However, it is relatively simple to build some devices thought complicated with materials that are commonly available in electronic shops. For example, measurement of alcohol used to require sophisticated gas chromatography. With commonly available sensors, like a “MQ3 gas sensor” available…