Article: AMD LASERS Obtains Certification in ISO 13485.

AMD LASERS announced it has attained International Organization for Standardization (ISO) 13485:2003 certification of its medical device quality management system in North America, Canada, and the European Union. In addition, the quality management system demonstrates conformance to the Medical Device Directive 93/42/EEC, allowing the products to be CE marked, which makes them available to be sold in the European Economic Area (see also AMD Lasers).

ISO 13485:2003 is the internationally recognized standard for the development, production, and servicing of medical products. In order to obtain ISO 13485 certification, a company must "demonstrate the ability to ...

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