SOURCE: Intertech

June 13, 2005 10:01 ET

Validating Software for Medical Devices: Do the Right Thing, Intertech's Vogel Urges Non-Software Engineers at MD&M Conference

NEW YORK, NY -- (MARKET WIRE) -- June 13, 2005 -- Non-software engineers validating software used to design, develop, manufacture and provide quality control for medical devices must "do the right thing," David A. Vogel, Ph.D., president of Intertech Engineering Associates, told the Medical Design & Manufacturing East Exposition and Conference in New York today.

"Only you can tell when you've done the right thing," he said. "It means you've done all you can to convince yourself that the software will fill the user's needs and will perform consistently and safely. You've focused your efforts and resources on activities that add value to the above conclusion. You've not spent a lot of resources on useless superficial testing to impress inspectors with the 'thud' value of your testing results."

Non-software engineers can easily validate firmware, embedded-tool software, off-the-shelf software used for statistical process control and calibration, configurable and programmable off-the-shelf software, and operating systems, he said. But the validation of large-scale, high-risk software probably should be left to the quality and software engineers.

Key questions are: Is the software regulated or not? How severe would a failure of the software be? How much and what types of validation are needed?

"Your risk analysis must consider intentional or unintentional misuse of available functionality even if it is not relevant to your intended use," he pointed out. "Think 'globally' beyond your software item. Are cross-checks in place that would detect or correct failures of the software item?"

--  Can verification processes or procedures be implemented outside the
    software item to verify its operation on a result-by-result basis?
--  Will a hazardous failure be detectable?  What can you do to make it
    detectable?
--  What is likelihood of software failure?  What can you do to reduce the
    likelihood of failure?  How will you know if you have reduced it enough?
--  Control risk as high on the harm-to-cause tree as possible, he
    advised.
    
Vogel said he hopes to hold a more in-depth version of this workshop that makes use of real-world examples provided by attendees.

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 a 100% safety record.

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

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