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Medical Device Software Validation Myths Exposed by Intertech CEO.

MINNEAPOLIS -- There are three myths about software validation: validation is the same thing as testing, verification is the same thing as testing, and the combination of verification and validation is the same thing as testing, David A. Vogel, president of Intertech Engineering Associates, Inc., told the Medical Design & Manufacturing Show in Minneapolis.

"The myths lead people to think that validation is a one-time event. But validation takes place throughout the software lifecycle," he said.

Testing is only one of several components of validation, said Vogel, whose firm serves the medical device industry with verification and validation services, plus hardware and software development engineering.

Validation, by the FDA's definition includes

--Quality planning, which covers planning for risk management, configuration management, software quality assurance, software verification and validation, and formal design-review requirements.

--Software safety, which ensures that software does not itself cause or contribute to a system hazard and implements risk-control measures to control hazards from all causes. "Safety activities are part of an iterative process that repeats itself at every phase of the software lifecycle," Vogel said.

--Documenting requirements, including system requirements, system/product specifications, and allocating system requirements to software, hardware, COTS and science (reagent, chemistry, optics, etc.) Software documentation includes functional, performance and physical requirements. "Getting the requirements right reduces the cost of producing software," he said.

--Design--completely and correctly translating system and software requirements into a symbolic and logical format that will support the organization and efficient generation of software code. This includes defining the system architecture and capturing the appropriate behavior and interaction of components.

--Development to establish a high degree of confidence that the software design is completely and correctly implemented into operable software code. "Only a small part of software engineering is programming or coding," Vogel noted.

--Testing. Developers should not be the only testers of their own code. Set up checks and balances, and use most the experienced and talented testers to review test designs and results, Vogel advised. "Just because you haven't found any errors, it doesn't mean that your software is perfect. It may mean that your testing was superficial."

--User site testing takes place onsite by the intended users with the actual hardware and software that will be part of the installed system. "A system may be great in the lab, but at the hospital, you may find that it's too hard to use, that the nurses or technicians don't understand the instructions and so on," he said.

--Maintenance includes revising the software validation plan, anomaly documentation and evaluation, assessment of proposed changes and updating documentation.

Intertech, in Norwood, Mass., offers product feasibility, specification, development and testing services, and workshops and training to medical device manufacturers nationally. Web site:
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Publication:Business Wire
Date:Nov 30, 2004
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