North Wales, PA, November 9, 2016
DEKRA Certification, Inc. has achieved ISO 13485 “Medical Devices — Quality Management Systems—Requirements for Regulatory Purposes” accreditation from ANAB.
“Our focus with ANAB accreditation for ISO 13485 is to help component manufacturers and service providers find a cost effective solution for achieving a certification based on the unique requirements of their business,” explains Chris Carson, Director of Business Development and Marketing for DEKRA Certification, Inc. “Our medical division already has DAkkS Accreditation for ISO 13485 as part of their Notified Body work with Medical Device Manufactures for CE marking other regulations around the world. Through our ANAB accreditation to ISO 13485 we are able to assist those companies in that sell to Medical Device Manufactures.”
As a standalone ISO standard, ISO 13485 adapts the world standard for quality management systems specifically to the need of the medical device manufacturing industry. The standard empowers manufacturers to guarantee their quality management systems are of the highest caliber and ensure an ongoing commitment to strong safety practices.
About DEKRA Certification, Inc.
DEKRA Certification, Inc. (DCI) is a U.S. based accredited Certification Body for international management systems. The company is part of the global footprint of DEKRA Certification Group headquartered in Stuttgart, Germany. DEKRA is a multi-accredited certification body covering all management system business line activities for North America, with a global service capacity. DEKRA offers services for ISO 9001 (quality), ISO 14001 (environment), ISO 13485 (Medical), AS 9100 (Aerospace), TS 16949 (automotive), ISO 50001 (energy management), ISO 27001 (Information Security) and other certifications. DCI’s Business Assurance group provides customized assessments in such areas as Sustainability, Energy Performance, Responsible Supply Chain, and Value Chain Risk, and many other areas. DEKRA works with companies to utilize standards for greater productivity, reduced waste, larger profits, an enhanced customer experience and the growth of a continuous improvement culture. DEKRA’s experienced professionals have extensive knowledge of management system standards and a proven track record of success to help achieve the goals of any organization. For more information visit www.dekra-certification.us.
DEKRA SE is one of the world’s leading expert organizations and currently runs activities in more than 50 countries on all five continents. About 35,000 employees are committed to ensuring long-term safety, quality and environmental protection. The DEKRA Business Units “Automotive”, “Industrial” and “Personnel” provide professional and innovative services in the fields of vehicle inspection, expertise, claims services, system certification, product testing & certification, industrial & construction inspection, consulting, qualification and temporary work. In 2014, DEKRA generated sales totaling approximately 2.5 billion Euros.