NORTH WALES, Pa., Oct. 27, 2020 /PRNewswire/ — DEKRA Audits has certified Northeast Biomedical’s quality management system to the ISO 13485:2016 standard for contract design, manufacture, and distribution of products and services for the medical and commercial industries. Northeast Biomedical is a manufacturing and distribution company based in Tyngsboro, Massachusetts, with experience in developing a wide variety of medical device products and instrumentation.
“Throughout the audit process, the Northeast Biomedical team was open, interactive, and a pleasure to work with, demonstrating effective quality management processes,” said Dr. Cem Onus, Managing Director of DEKRA Audits. “We are proud to issue their certification to ISO 13485:2016, and I congratulate the NEB team on this accomplishment.”
ISO 13485:2016 is the latest version of the internationally recognized ISO 13485 standard. Derived from the ISO 9000 series of quality management system standards, ISO 13485 details the requirements for a management system, with a specific focus on organizations involved in the design and manufacture of medical devices.
“This certification helps our engineering process and lets potential clients know we are a top-performing product development team. We are really excited as a team that we achieved such a sought-after certification, and I could not be more proud of our achievement,” said Timothy Looney, President of Northeast Biomedical.
DEKRA Certification, Inc. (DCI) is a U.S.-based multi-accredited certification body for international management systems according to ISO 9001 (quality), ISO 14001 (environment), SEP (Superior Energy Performance), ISO 50001 (energy management), ISO 27001 (Information Security) and others. It is part of the global footprint of DEKRA SE, headquartered in Stuttgart, Germany. DEKRA works with companies to utilize standards for greater productivity, larger profits, an enhanced customer experience, and the growth of a culture of continuous improvement.
Founded in 2011, Northeast Biomedical (NEB) delivers top-performing medical devices and consulting advice for clients. The NEB development team consists of highly-skilled engineers who help companies navigate all stages of product development, with a focus on efficiency and shortened market launch timelines. A seven-phase approach is used that emphasizes versatility, accountability, and capability. Product development services offered include: Medical device design, electromechanical instruments, catheters, disposable design, equipment development, surgical/other robotics, and contract manufacturing.
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SOURCE DEKRA Organizational Safety and Reliability