AMD LASERS Obtains Certification in ISO 13485 |
INDIANAPOLIS, Nov. 2 /PRNewswire/ -- AMD LASERS today 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.
(Photo: http://www.newscom.com/cgi-bin/prnh/20090414/DE98219)
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, a renowned 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."
About AMD LASERS
AMD LASERS, founded in 2006, is the global leader at providing
comprehensive and affordable laser technology for dental professionals
preparing to take their practice to the next level. The integration of
Picasso, our high quality laser technology, enables thousands of dental
practices to provide advanced patient care with ease. Our clients also
receive full-service customer care support from our knowledgeable and
friendly staff. For more information about AMD LASERS, please call
866-999-2635, +1-317-202-9530, or visit us online at http://www.AMDLASERS.com.
SOURCE AMD LASERS
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CONTACT:
Joyce Townsend, +1-317-202-9530, ext 110,
joyce.townsend@amdlasers.com
