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For more than twenty years, the U.S.
Food and Drug Administration has identified
insufficient design controls as a major
factor in product recalls. In 1990
FDA published a study based on 5 years of
recall data showing that nearly half of
all recalls were due to deficiencies designed
into the product. A seven-year FDA
study published in 1991 showed that 90%
of software-related device failures were
design-related. These studies make
a strong case that an effective design control
system is critical in avoiding consumer
safety issues and minimizing the crippling
effects of recalls on your company’s reputation
and bottom line.
Our Associates have
taught design controls publicly, and at
GlobalReg we’ve translated the mystique
of the design control regulations into a
reliable, proven, and sustainable system.
Whether you’re striving to meet FDA’s
Quality System Regulation design requirements,
or the product realization requirements
from ISO 9001:2000, or both, we are equipped
to implement a design control system that
is the right fit for your company, and proportional
to the risk level of your products. We
invite you to tour the following design
control services offered by GlobalReg:
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