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ISO Certifications.

* Dongbu HiTek, a Seoul, South Korea-based provider of analog and mixed-signal processing technology, has achieved ISO 13485:2003 certification. Company executives said the achievement will enable the foundry to target its integrated circuits to North American and European markets.

* ISO 13485;2003 certification has been given to Gilero Biomedical, a full-service pharmaceutical and medical device design and product development firm headquartered in Research Triangle Park, N.C. Company executives said the certification strengthens Gilero's commitment to product quality and customer service. "The ISO certification is a significant accomplishment and an important milestone for Gilero's 10th year in business," President and Chief Technology Officer Ted Mosler said. "Certification has been one of our top business priorities because it is important to our customers."

* ISO 13485:2003 certification has been awarded to RTEmd, a Pittsford, N.Y.-based provider of custom software design, development and testing for complex medical equipment. The achievement, according to executives, will add more value to the company's partnerships." RTEmd's work is exclusively for manufacturers of medical devices, each of whom typically abide by this standard," President Bob Ruppenthal noted. "This new certification will enable us to add more value in partnership with our clients by being certified against the same standard they uphold."

* Web Industries Inc., a Marlborough, Mass.-headquartered contract manufacturer, announced that its Hartford, Conn., facility is now an official U.S. Food and Drug Administration-registered establishment. The registration will enable the firm to offer expanded contract manufacturing and converting services in the medical device and diagnostics sectors." ... FDA registration of the Hartford location show Web Industries' continued commitment to and investment in comprehensive quality management systems and procedures," Chief Operating Officer Mark Pihl said." More importantly, it demonstrates our focus on managing risks and meeting regulatory requirements in order to ensure our customers' success in their markets."
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Title Annotation:Industry News
Publication:Medical Product Outsourcing
Date:Apr 1, 2012
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