ModusLink Global Solutions Inc. has received ISO 13485 certification for the supply chain management of medical devices. Based in Waltham, Mass., ModusLink provides 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.
“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 of global operations at 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 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 of ChainLink Research, a supply chain research and advisory company. “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.”