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It is important to distinguish among three concepts; identification, tracking, and tracing. They are different, but may have some overlap. In the US system: Identification tells us what the device is Tracing provides information about critical devices and their components Tracking provides information ...

I'll address the first question only. You need to be very cautious with the phrase "Research Use Only" in the context of medical devices (IVDs) in the US. RUO has two meanings. One is reagents not intended for use in humans. For example, your company might sell reagents with the intention of research ...

If something happened to an end user and you learned about it, then you will initiate a complaint under 820.198. The complaint triggers an investigation to determine if it is reportable as a Medical Device Report, MDR, under Part 803. From the brief description, I would expect it is reportable. You ...

Attached ------------------------------ Dan O'Leary CQA, CQE Swanzey NH United States ------------------------------