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...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.