Medical-Device Software Validation for the "Rest of Us" to Be Covered at MD&M East

NORWOOD, MA -- (MARKET WIRE) -- May 7, 2007 -- Non-software engineers responsible for validating medical device software can learn how to do it right during the Medical Design & Manufacturing East Exposition and Conference in New York.

The workshop, "Software Validation: Development, Production, and Other Quality System Software for the Rest of Us," will be held June 14 at the Jacob K. Javits Convention Center. It will be presented by David Vogel and Robert Barrett of Intertech Engineering Associates, Denise Stearns of Boston Scientific, and John Murray of the FDA.

"This will be a unique opportunity to learn from some of the Association for the Advancement of Medical Instrumentation (AAMI) workgroup participants and to hear the FDA's current thinking," Vogel said.

The workshop will cover:

--  Thinking about validation in a new way -- "Software Compliance
    Science"
--  An overview of AAMI's upcoming technical information report
--  Hypothetical examples of what can go wrong with software
--  How validation activities add protect you from unacceptable software
    risks
--  A validation approach for non-software engineers
--  Understanding Part 11 (Electronic Records and Signatures)
--  Hypothetical examples of Part 11 validation activities
    

Validation of software used to automate any part of a device manufacturer's quality or product system is required by FDA regulation, which covers software used for many applications as well as software embedded in production machinery.

To register online, visit www.devicelink.com/expo/east07/conference_401.html

Vogel, president of Intertech Engineering Associates (www.inea.com) is a top expert on medical software validation. He can be reached at 781-255-5420 or dav@inea.com.

Contact Information: Contact: Henry Stimpson Stimpson Communications 508-647-0705 HStimpson@StimpsonCommunications.com David A. Vogel Intertech 781-255-5420 dav@inea.com