Sciemetric wins major quality control contract in medical device
27 February 2009
Sciemetric Instruments, whose assembly manufacturing quality systems
are used by companies around the world to detect and analyze
manufacturing defects as they occur, has been named a preferred supplier
to one of the world’s largest medical device manufacturers, cementing
its position in a key growth market for the company.
To achieve this status, Sciemetric underwent a stringent software
quality audit whose requirements were more exacting than those found in
international standards such as those published by the International
Organization for Standardization (ISO).
The manufacturer is a multibillion-dollar global enterprise that
includes under its umbrella hundreds of companies operating in over 50
countries. As a preferred supplier, Sciemetric is free to pursue
business from these operating units that are involved in medical device
and pharmaceutical production. Its Process Signature Verification
technology will help precisely monitor and characterize processes and
products to achieve zero-defect manufacturing and traceability.
Sciemetric’s technology will also greatly enhance the manufacturer’s
compliance with the U.S. Food and Drug Administration’s 21 CFR Part 820
quality system regulation for medical device manufacturing. Against the
backdrop of a recessionary economy, improved product quality and fewer
defects allows for leaner and more cost-competitive manufacturing
"There is a strong appetite in the medical device and pharmaceutical
industries for improved manufacturing and quality-control techniques
that were previously unavailable," said Nathan Sheaff, founder and CEO
of Sciemetric. "These are industries where lives literally depend on the
quality of the products coming off of the line. With this preferred
supplier status, we have proven ourselves capable of not only meeting
the high standards demanded by a major player in this market, but also
of helping them to further improve the quality, safety and efficiency of
their manufacturing operations."
For almost 20 years, Sciemetric has been helping the largest
manufacturing companies in the automotive, industrial component and
medical sectors detect and analyze the root causes of defects in real
time using a unique combination of superior on-the-floor
defect-detection testing and sophisticated off-line analysis and
reporting. Sciemetric’s technology dramatically reduces defects and
incidents of product recall that are both costly and damaging to a
manufacturer’s brand and reputation.
Today’s announcement marks a significant milestone for Sciemetric in
terms of its presence in this market and its goal to further diversify
its business beyond the automotive sector.
"This is an exciting and new area of growth for us," said Sheaff. "We
believe this relationship provides Sciemetric with the same strong
foundation from which to grow in the medical device market that Ford
Motor Co. provided us in the automotive market in the 1990s. While the
application is different, the technology behind it is the same."
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