SOURCE: Intertech

May 27, 2005 09:49 ET

Medical-Device Software Validation Workshop for Non-Software Engineers to Be Presented at MD&M East

Intertech's Vogel Teaches First-Ever Course for Non-Specialists, Monday, June 13

NORWOOD, MA -- (MARKET WIRE) -- May 27, 2005 -- Non-software engineers responsible for software validation at medical device companies can learn the basics from expert David Vogel, Ph.D., president of Intertech Engineering Associates Inc., at the Medical Design & Manufacturing East Exposition and Conference in New York.

The three hour workshop, "Validation for the Non-Software Engineer: Quality, Design, Development, and Manufacturing System Software," will be held Monday, June 13.

"It's the first seminar for production, quality and mechanical engineers and managers who don't have a background in software or validation but who are responsible for validating the software they use. This will get them off to a great start," he says.

The workshop will cover:

--  Regulatory background and requirements for validation of quality
    system software
--  Coverage of the FDA guidance(s) related to quality system
    software validation
--  Components of validation
--  How to determine if software is regulated or not
--  Using risk management to drive your validation efforts
--  How to determine how much validation is recommended
--  Dealing with off-the-shelf, custom, and hybrid software packages
--  Validation of Part 11 software
    
Attendees can bring in real-world examples from their jobs. For more information, view www.devicelink.com/expo/east05/conference.html and look for Session 103. Vogel also co-teaches Session 107, an advanced seminar aimed at software engineering, quality, and regulatory-compliance professionals.

Founded in 1982, Intertech has served the medical device industry by providing electronics hardware and software development services. Vogel and his Intertech team have developed engineering processes that facilitate product design compliance with FDA Quality System Regulations (QSR). The product verification and validation services provided by Intertech have had a 100% safety record.

Vogel received a BS in electrical engineering from M.I.T. and earned a master's degree in bioengineering, a master's degree in electrical and computer engineering, and a doctorate in biomedical engineering from the University of Michigan.

For more information, contact Vogel at 781-255-5420 or dav@inea.com. Web: www.inea.com.

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