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In SoftwareCPR training classes on IEC 62304 and FDA regulation, we sometimes use a fabricated example of a vertical slice of software documentation. This example includes requirements specification, risk analysis, design, and testing along with commentary for one functional area. The linked document provides this using the calibration portion of an IVD for general training purposes. This was prepared by Raffaele Caliri, a partner at SoftwareCPR.

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