News & Events

Important Publications

AAMI TIR36:2007 Validation of Software for Regulated Processes 
From AAMI's announcement of the TIR: "Throughout the life of software that is used to automate regulated processes — such as the design, manufacturing, and packaging of devices — appropriate controls must be in place to ensure that the software performs as intended.

To help manufacturers navigate this rugged terrain, AAMI has just published a new technical information report (TIR) called TIR36:2007, Validation of software for regulated processes, which offers guidance on appropriate software validation methods and tools."

David Vogel from Intertech was a member of the workgroup that developed this Technical Information Report.  Dave has lectured and written about the work done in this work group for the last several years.  You can order your copy of the TIR from AAMI at  http://www.aami.org/publications/AAMINews/2008Feb/tir36.html

Library
FDA Documents - FDA's Design Control Guidance was added.  It's not a new release .. just inadvertently dropped when we redesigned the website.

New Additions to our Intertech Reprint Library
Eight new articles were added to our online library  March 1, 2008 .

Announcements and Press Releases

MD&M East - New York - June 3-8, 2008
Robert Barrett and David Vogel will give a workshop on Design Transfer at the MD&M tradeshow in NY in June.  More details to follow ...

Intertech will be exhibiting at the MD&M Tradeshow in New York, June 3 through 8.  Come by to see us at booth 2778.

We have access to a limited number of discounted admission tickets to all MD&M conference events for colleaguues, prospects, and clients of Intertech. Simply contact us at seminar@intertechengineering.com for details - BEFORE YOU REGISTER ONLINE.