- Value Unchained, the blog for supply chain professionals.
- More information on the International Standards Organization.
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