Index

News & Events

         Current Topics on Software Validation - MD&M Anaheim, February 8, 2010

         Intertech Exhibiting at BIOMEDevice Boston, April 21-22, 2010

            
Publications
         New Textbook Coming!
         Software Validation in the Medical Device Industry - David Vogel, Ph.D.
         Anticipated publication date: October 2010, Artech House Publishing
         More details to follow ...  Title may change as publication nears.
         

         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

MD&M West - Anaheim, CA - February 8, 2010
Current Topics on Software Validation
   John Murray, FDA  
   David Vogel, Intertech Engineering Associates, Inc.
   Carl Wrywa, Beckman Coulter

Ten topics in a six hour workshop:

   Compliance Basics – The 5 Tools – Regulatory Authority
   Software Verification and Validation, What They Are and Aren’t
   The Role of Risk Management, Use Error Analysis, Human Factors in Validation
   FDA Facts and Myths
   Medical Device Software Validation
   Quality System Software Validation Production and Process Controls
   Lifecycles and Their Role in Validation
   Compare and Contrast Device Software Design Validation (820.30(g)) and    
        Production and Process Controls - Automated Systems Software Validation (820.70(i))
   External Standards:  62304
   Part 11 Update, Software Compliance Update and Outlook

 

Click here for full abstract.    Click here to register.

 

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      BIOMEDevice Boston 
      April 21-22, 2010
      Boston Convention Center

      Come visit us at booth 1004!

      Click here for more on the expo.

      Click here for free expo pass coupon.

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AAMI Webinar - October 8, 2008, 11 am EDT - Recorded Version Still Available
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.

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 .

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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