SOURCE: Intertech

February 09, 2007 09:52 ET

Following Medical-Device QSR Shortens Product Development, Intertech's Vogel Writes

Regulations Spur Faster Development of High-Quality Embedded Software

NORWOOD, MA -- (MARKET WIRE) -- February 9, 2007 --The FDA's quality system regulation, or QSR, is often seen by medical-product software developers as a nuisance that slows product development, but following it helps speed development, David A. Vogel, Ph.D., president of Intertech Engineering Associates, writes in the January issue of Medical Device & Diagnostic Industry.

"Understanding and following the good engineering and project-management principles outlined in the QSR can help manufacturers shorten the development cycle. Not only is the time to market faster, but the end result should also be a more stable, more reliable, and higher-quality product. The difference in both timeliness and quality can be enormous," he writes.

The regulations require developers to plan before they act -- a step too often overlooked. No builder would pour concrete without building forms first, but some software developers do the equivalent by coding before they have requirements settled.

"Software without a detailed set of requirements or specifications is like wet concrete without forms. It must be shaped and reshaped, designed and redesigned, until it hardens. If the end result doesn't meet the customer's needs, software, like concrete, becomes difficult to change late in the project," Vogel writes.

And, like concrete, patched-up software isn't as structurally sound.

Some think that design control requirements stifle the creativity of the programmers and software engineers. That's not true because the requirements apply only to the development phase, not the research phases, he asserts.

But they do speed the product-development process.

"Gathering requirements, communicating through written documentation and verification of testing activities are three areas that are critical to increased efficiency. Gathering requirements early cuts down on the number of implementation iterations. By starting the implementation process before the requirements and designs are complete, people get a false sense that the schedule is being advanced," Vogel writes.

The full article can be read at

Intertech Engineering Associates, Inc. ( in Norwood, Mass., provides hardware and software development, requirements and quality engineering, product validation services, training and consulting for medical device manufacturers.

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