ATEK Medical Receives ISO-13485:2003 Certification and FDA Registration for
Costa Rica Manufacturing Facility
Recognizing the highest standards of quality, the ISO certification and FDA approval affirms ATEK’s ability to serve client manufacturing and distribution needs
GRAND RAPIDS, MICH. (Oct. 3, 2008) – ATEK Medical, a division of ATEK Companies, announced today that its new 33,000-square-foot medical device manufacturing facility in Heredia, Costa Rica is ISO-13485:2003 certified and is also registered with the Food and Drug Administration (FDA).
The ISO 13485:2003 certification is based on an inspection earlier this year by TUV America and demonstrates ATEK Medical’s continuing commitment to international quality management system standards.
“At ATEK, we have always been committed to excellence,” said Chris Oleksy, president, ATEK Medical. “The ISO certification and FDA registration demonstrates that our focus — whether in Grand Rapids or Heredia — remains on quality, world-class performance and continuous monitoring of our business operations. This commitment ensures that we deliver on the promises we make to our clients and in turn that our clients make to their customers.”
Located 9 miles or about 14 kilometers north of San José in a Free Trade Zone, ATEK Medical’s Costa Rica facility specializes in Class II single-use and electro-disposable device, and Class III implantable device manufacturing. All aspects of the facility were designed for compliance to ISO-13485 standards for medical device production. The facility opened in October 2007 and will soon be at full operating capacity.
“From the initial phases, we worked very hard to prepare our facility for the ISO auditing process,” said Jorge Vargas, Costa Rica general manager, ATEK Medical. “The certification was a critical milestone for our operations. We are proud that we were able to gain our ISO certification in a short period of time – it is a testament to our commitment and expertise.”
Developed by the International Organization of Standards, ISO 13485:2003 is a stand-alone medical device quality system standard specifically intended for the medical device industry focusing on regulatory quality system requirements. Published in 2003, the standard represents the requirements for a comprehensive management system for the design and manufacture of medical devices.
For additional information about ATEK Medical, please visit www.atekmedical.com
About ATEK Medical
ATEK Medical, based in Grand Rapids, Mich., is the preferred manufacturing solutions provider serving the medical device and biotechnology markets. ATEK Medical capabilities include disposable and electro-mechanical medical device development, launch, assembly, manufacturing, packaging, labeling, microbiology services, sterilization management, supply chain management, and distribution services. ATEK Medical has developed and launched more than 350 unique products and specializes in product/program management and full-service manufacturing. ATEK Medical is part of the privately held ATEK Companies, which distinguishes itself from the competition through its 60-year history, breadth of capabilities, long-term strategic partnerships with customers and suppliers, responsive culture, global presence, and regulatory expertise. ATEK Medical is ISO 13485:2003 certified, IPC-610 certified, UL-registered, and FDA registered to design, produce and launch Class I, II and III medical devices. For more information on ATEK Medical and ATEK Companies, visit www.atekmedical.com
About ATEK Companies
ATEK Companies is the preferred manufacturing partner serving diverse industries including medical, aerospace, defense, communications, and transportation. ATEK Companies distinguishes itself from the competition through its 60-year history of delivering unparalleled value, high quality products, and creative solutions. ATEK Companies offers total project management, including electrical and mechanical product design and launch, supply chain management, production, packaging and distribution, and post-production fulfillment services. ATEK Companies is comprised of five businesses, which include ATEK Medical, ATEK Manufacturing, ATEK Plastics, ATEK Products, and Progress Casting. Facilities are located in Minneapolis and Brainerd, Minn.; Kerrville, Texas; New Hampton, Iowa; Grand Rapids, Mich.; and Heredia, Costa Rica. For more information visit www.atekcompanies.com
PDF Version