Software Documentation Training Example

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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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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

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