OrthoGrid® Systems earns ISO-13485:2016 certification for medical device quality system
New designation reflects company’s continuing growth, increasingly globalized footprint
SALT LAKE CITY, UTAH, September 11, 2018 – OrthoGrid® Systems, Inc., a leading innovator of physician-assistive alignment technology for orthopedics, today announced that the company has received ISO 13485:2016 certification for its medical device quality system.
“Our expanding customer list and broadening distribution inside and outside the USA, combined with accelerating R&D activities, made the timely pursuit of ISO 13485:2016 certification a priority for our team, noted Edouard Saget, President of OrthoGrid® Systems. This quality system designation is an important step forward as we transition into the next phase of our commercialization and product development strategies.”
According to the International Organization for Standardization, ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
Orthopedic surgeon Erik Kubiak, MD, noted that “OrthoGrid® Systems’ technologies are exceptionally innovative and the incorporation of a robust quality system for all of their current and future products is increasingly important for physicians, hospitals, and patients.”
OrthoGrid’s patented technologies include the HipGrid® 12-Inch System, HipGrid® NINE 9-Inch System and PhantomMSK™ Hip, all available for sale in the USA through OrthoGrid’s sales & service team. Please visit our website at www.orthogrid.com to learn more about our company and how to schedule a free product trial of any OrthoGrid® Systems technology.
About OrthoGrid® Systems, Inc.
OrthoGrid® Systems is a dynamic global leader in the development & commercialization of physician-assistive alignment solutions for orthopedic surgery. Designed to interface with existing hospital equipment and engineered to reveal fluoroscopic distortion, OrthoGrid’s unique solutions and technologies empower surgeons to make more informed intraoperative decisions. Specialized products and applications are currently available or in development for total hip arthroplasty, trauma, and other common procedures performed over 1 million times per year in aggregate in the USA and 3 million times globally. Learn more about OrthoGrid® and our products by visiting our website at www.orthogrid.com.
Source: OrthoGrid® Systems, Inc.
Media Contact: Mark Carrico, Director of Marketing
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