Medical imaging and security systems maker Analogic Corp. (ALOG) Monday said that its newly established China operations, Analogic Medical Equipment Co., Ltd., has received ISO 13485 certification and shipped its first MRI amplifier product. The new Shanghai facility, which opened on December 2009, will incorporate sales, marketing, engineering, and manufacturing services as well as house a regional repair depot, the company noted.
Peabody, Massachusetts-headquartered Analogic expanded into China as part of its strategy to increase its global commercial footprint and reduce its supply chain costs. The company said that a local presence will enable it to fully support its customers in the region and to benefit from China's emerging market growth.
ISO 13485 standard, published in 2003, specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. It includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.
Chief Executive Officer Jim Green said, "China's rapid economic growth, coupled with an aging population, has increased the region's demand for advanced medical imaging technology and presented a tremendous business opportunity for Analogic."
ALOG is currently trading at $46.64, up $0.44 or 0.95%, on the Nasdaq.
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