INDIANAPOLIS, Indiana--AMD LASERS has announced attainment of International Organization for Standardization 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. This makes them available to be sold in the European economic area.
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."
"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.
"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."
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