EDEN PRAIRIE, Minn. -- Data storage and server integration specialist Rorke Data, a subsidiary of San Jose-based Bell Microproducts, Inc. (NASDAQ:BELM), has achieved ISO 13485:2003 certification. The worldwide medical device and diagnostic imaging community developed ISO 13485:2003 in an effort to standardize quality management systems across the supply base. Over the past 22 years, Rorke Data has become a leading supplier of data storage systems, components, servers and network infrastructure solutions to the worldwide Healthcare and Imaging system and application manufacturers.
"We are excited to offer our medical customers a Quality Management System compliant with the requirements of ISO 13485:2003 for medical devices," said Fred Coller, Director of Quality Management at Rorke Data. "Our 13485 Quality Management System was built on the strengths already contained in our 9001:2000 Quality Management Systems, with some additional requirements for the medical industry. Whatever devices they produce, medical device manufacturers have a responsibility to consistently deliver devices that are safe and effective. ISO 13485:2003 is the international standard recognized for medical device Quality Management Systems registration."
"As high-capacity data storage systems, along with high-bandwidth servers and network products, emerge as integrated key components of an overall medical device or imaging solution, earning the ISO 13485:2003 certification instills confidence in our partners," said Tim Hanscom, Vice President of Healthcare Sales at Rorke Data. "Our customers are leading Diagnostic Imaging and Medical Device OEMs; they rely on us as subcontractor, and with ISO 13485 certification, they can effectively monitor our commitment to this important quality system enhancement."