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Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

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Synopsis

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device?  In this episode of the Global Medical Device Podcast, Jon Speer talks to Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS).Jon and Milton discuss practical pointers for determining and describing the similarities and differences between the two types of devices. Milton also offers some helpful recommendations for IVD manufacturers to consider when it comes to regulatory compliance and their quality system.Some highlights of this episode include:An IVD consists of the agents, instruments, and systems used for the diagnosis of disease or other health conditions, such as HIV, hepatitis, diabetes, and flu.From a patient perspective, the IVD is not invasive. A sample of something, such as saliva, urine, or blood from the patient is taken. Then, the sample is prepared and put through an IVD for analysis to determine the results of a specific test. An