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News ScottCare Achieves ISO 13485 Quality Certification ScottCare has achieved its first ISO13485-2003 Certification upon completion of an audit by TÜV America, an independent ISO registrar. ISO13485 is the internationally recognized standard for quality management in the design, manufacture and service of medical devices. While ISO shares many of the same requirements as those mandated by the US FDA Good Manufacturing Practices (GMP), it expands and extends them into a comprehensive quality system. While ScottCare has always complied with FDA GMP, the world market requires a focus on international standards. For example, ScottCare recently won approval to market its products in Canada as a result of the ISO 13485 certification. “The process of achieving ISO13485 certification provided us with an opportunity to review all of our operating procedures and to identify areas in which we could operate more efficiently and effectively”, said Ken Zajczkowski, President of ScottCare. “I expect our customers will see improvements resulting from these efforts in the coming months.”
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