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ModusLink Receives ISO 13485 Certification For Medical Device Manufacturers

Stocks in this article: MLNK

ModusLink Global Solutions™ Inc. (NASDAQ: MLNK) is announcing its Solution Centers in Raleigh, North Carolina and Brno, Czech Republic have achieved ISO 13485-based certification for the supply chain management of medical devices. ISO 13485 is the globally recognized standard that outlines consistent international processes for the design and manufacturing of medical devices, including many supply chain functions such as assembly, packaging, warehousing and distribution.

ModusLink supports multiple services for medical device manufacturers including lot and batch traceability of products; postponement and final device configuration in process-controlled environments; secure warehousing and channel operations; and documented returns management. Currently, ModusLink is working with clients who are bringing non-invasive devices to market, such as patient monitoring systems and oral care products.

“ISO certification in the medical devices supply chain involves the demonstration of significant quality management systems and this certification marks a major step forward in our supply chain management capability for the medical device sector,” said Scott Crawley, president, global operations, ModusLink. “With ISO 13485, we are extending the world-class packaging, warehousing, postponement and fulfillment services we currently perform for the leading companies in the computing industry to the fast-growing medical devices market.”

According to a 2012 report from iData Research, the U.S. market alone for patient monitoring devices is expected to grow to more than $4 billion USD by 2018.

“As with any fast growing market, stress is put on the supply chain. Therefore the medical devices industry needs stable, highly reliable end-to-end supply chain partners to achieve that growth potential,” said Ann Grackin, CEO, ChainLink Research. “One thing they don’t want to worry about is compliance. Strict industry regulations place an added burden on that supply chain and ModusLink’s ISO 13485 certification can help its clients get to market quickly with the required quality systems in place.”

Additional Resources

About ModusLink Global Solutions

ModusLink Global Solutions Inc. (NASDAQ: MLNK) executes comprehensive supply chain and logistics services that improve clients’ revenue, cost, sustainability and customer experience objectives. ModusLink is a trusted and integrated provider to the world’s leading companies in consumer electronics, communications, computing, medical devices, software, luxury goods and retail. The Company’s operating infrastructure annually supports more than $80 billion of its clients’ revenue and manages approximately 470 million product shipments through more than 30 sites in 15 countries across North America, Europe, and the Asia/Pacific region. For details on ModusLink's flexible and scalable solutions visit www.moduslink.com and www.valueunchained.com, the blog for supply chain professionals.

This release contains forward-looking statements, which address a variety of subjects including, for example, the expected benefits of the ISO 13485 certification and expanded service offering described herein. The following important factors and uncertainties, among others, could cause actual results to differ materially from those described in these forward-looking statements: the Company’s success depends on its ability to execute on its business strategy and the continued and increased demand for and market acceptance of its solutions and services, including the expanded offering described herein; the Company may not be able to expand its operations and capabilities in accordance with its business strategy; the Company may experience difficulties integrating technologies, operations and personnel in accordance with its business strategy; the Company derives a significant portion of its revenue from a small number of customers and the loss of any of those customers would significantly damage its financial condition and results of operations; increased competition and technological changes in the markets in which the Company competes; and risks associated with international operations. For a detailed discussion of cautionary statements that may affect the Company's future results of operations and financial results, please refer to its filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Forward-looking statements represent management's current expectations and are inherently uncertain. ModusLink Global Solutions does not undertake any obligation to update forward-looking statements made by it.

ModusLink Global Solutions is a trademark of ModusLink Global Solutions Inc. All other company names and products are trademarks or registered trademarks of their respective companies.

Copyright Business Wire 2010

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