Software Documentation Training Example

In SoftwareCPR training classes on IEC 62304 and FDA regulation we sometiems use a fabricated exmple of a vertical slice of software documentation. This example includes requirements specification, risk annalysis, design and testing along with commentary for one functional area. The document at the link provided provides this using the calibration portion of an in-vitro diagnostic device for general training purposes. This was prepared by Raffaele Caliri a partner at SoftwareCPR.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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