$SoftwareCPR Medical Device SW Reference Manual$

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions.

This reference manual includes the following documents in a single pdf with bookmarks and a clickable TOC. Be sure to click bookmarks in adobe so you can jump around the document easily. This pdf contains key FDA software guidances plus a number of Software educational aides and article reprints.

It is a 2 MB adobe file so be patient downloading if you have a . . .

Thank you for your interest!  To view our Premium or Standards Navigator content, please click here to select the plan that best fits your needs.

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.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.