Index

News & Events
         AAMI Webinar - Murray & Vogel - Validation of Software for Regulated Processes
         MD&M - Minneapolis Workshops - Design Transfer and Design Control SOPs
    
Publications
         AAMI TIR36:2007 - Validation of Software for Regulated Processes

Announcements and Press Releases
         MD&DI Magazine's "Notable 100" Names Intertech President David Vogel

News & Events

AAMI Webinar - October 8, 2008, 11 am EDT
Validation of Software for Regulated Processes: An Overview of AAMI TIR36:2007
David Vogel of Intertech and John Murray of CDRH-FDA, both contributors to the Technical Information Report (TIR) will be co-presenting this webinar. The webinar will challenge the way medical device manufacturers think about validating regulated process software. Methods suggested in AAMI TIR36 discourage a checklist approach that is overly prescriptive. Instead, the TIR recommends an approach that emphasizes “critical thinking” and empowers those validating software to take innovative approaches to building confidence in the software for its intended use. The speakers will walk-though AAMI TIR36, introduce new validation concepts, and provide practical information on using the TIR to solve daily validation needs in a more value-added way.

More details about the webinar and online registration are available at AAMI's website.  Click for more details or registration ... 

If you were unable to attend the webinar live, you can purchase recorded versions from AAMI at http://www.aami.org/meetings/webinars/web.tir36/cd.form.pdf .

MD&M Minneapolis- October 21-23, 2008
In addition to exhibiting at Booth 552, Intertech will present two workshops at the MD&M MinneapolisConference.  Both workshops will be half day workshops on Thursday, October 23.  The morning workshop will be on the topic of Design Control SOP's: Good Organization and Careful Planning Improves Time to Market and Quality.  The afternoon workshop will be on the topic of Viewing Design Transfer as a Process.  Click for more details or registration ...Intertech will also be exhibiting at the concurrent Exhibition.  Come by to see us!

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.

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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/applications/search/details.cfm?webid=P855_D4668

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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 .

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Announcements and Press Releases

 MD&DI Names Intertech President to
"100 Notable People in the Medical Device Industry"
In its June 2008 issue, MD&DI magazine named Intertech president, David Vogel, to its list of "100 Notable People in the Medical Device Industry.  Quoting MD&DI :

"The medical device industry consists of products, processes, and technology. These are covered in almost every issue of MD&DI. But it also consists of people, without whom none of the amazing advances in medical science and technology would be possible.

In this issue, MD&DI honors some of the people who make these advances possible and who ensure that those devices can treat patients safely and effectively."

See the entire list at MD&DI's online version.

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