COLUMBIA, S.C., March 9 /PRNewswire/ -- Conformity markings allow Rhythmlink International products to be marketed throughout Europe, launching Rhythmlink to a new level within the neurodiagnostic and health care industry.
As of January 28, 2010, Rhythmlink International received ISO 13485:2003 certification, in combination with official CE markings, following MDD 93/42/ECC Directives. Rhythmlink's quality management system was audited in accordance with ISO 13485:2003 and is recognized by the Canadian Medical Devices Conformity Assessment Scheme [CMDCAS] and the Standards Council of Canada [SCC] accredited notified body, TUV Rheinland.
Effective immediately, Rhythmlink may sell and market product within the European Union [EU] and partnering nations. "Our ISO 13485:2003 certification is key to the growth of the company. This certification demonstrates to the markets in the European Union that Rhythmlink will provide products backed by a quality management system that reduces risk to patients," said Martin Barry, Rhythmlink International's regulatory affairs specialist.
As an electrode manufacturing company, within the medical devices industry, Rhythmlink International is bound by strict FDA regulations and regulatory requirements. Rhythmlink's quality management system has demonstrated the ability to provide medical devices and services that consistently achieve customer and regulatory requirements, thus receiving ISO 13485:2003 certification and ISO 13485:2003 + AC:2007 CE Markings.
Under European Directives and supported by European standards, Rhythmlink and its products are in full compliance with essential health and safety requirements. The CE Marking is Rhythmlink's declaration that all products meet the essential requirements of the European directives.
For more information about Rhythmlink's certifications, products and services, visit Rhythmlink.com.
About Rhythmlink International, LLC
Rhythmlink International, LLC designs, manufactures and distributes neurodiagnostic accessories and provides custom OEM and manufacturing solutions to its customers. Based in Columbia, S.C., Rhythmlink was established in 2002 and is owned and operated by CEO Shawn Regan and COO Michael O'Leary. Rhythmlink's advancements and improvements in the areas of technology, business development and corporate branding have been recognized by entities such as the Columbia Information Technology Council, Inc. Magazine and the International Academy of the Visual Arts. For more information about Rhythmlink International, its products or services, visit Rhythmlink.com.
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