Sciemetric wins major quality control contract in medical device sector

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 processes.

"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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