ISO/IEC 12207

“Information Technology – Software Lifecycle Processes” and issued August 1995. This document was the basis for development of the AAMI Medical Device Software Development Standard and was one of the first software standards recognized by FDA for submission purposes. It can be ordered directly from the IEC at www.iec.ch. Just go to their web store page and search on 12207. You will see the standard itself and some supporting documents. The standard can be ordered as a hard copy or an adobe pdf file.

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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