Dental News - AMD LASERS gains international certification for its Picasso diode laser

Fred Michmershuizen, DTA

Tue. 3 November 2009

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NEW YORK, NY, USA: With international certifications now in place for its Picasso diode laser, AMD LASERS is poised for continued growth in North America as well as expansion into the European market.

AMD LASERS, based in Indianapolis, IN, USA, 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.

“Achieving ISO 13485 certification further demonstrates our leadership and commitment to the highest standards of our industry,” said Alan Miller, president and CEO of AMD LASERS, in a news release announcing the certification. “We also have many potential customers in Europe eager to purchase the Picasso, so our ability to use the CE mark is another major step forward in our mission to provide advanced, affordable dental lasers around the world. It’s a proud day for our young company.”

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 provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services.

During the certification process, AMD LASERS partnered with TUV Rheinland, an international service group that serves as an ISO registrar, auditing the safety and quality of new and existing products, systems and services.

“It has been a pleasure to work with TUV Rheinland,” said Amy Szentes, compliance manager at AMD LASERS. “They are the gold standard in ISO registrars, and we feel this certification validates all of the hard work we have put into both product quality and compliance.”

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