Altimate Medical Receives Top Certification for Medical Device Quality Management
Morton/Redwood Falls, Minn. – Altimate Medical Holdings, Inc., announced this week that Altimate Medical Inc., received ISO 13485:2016 certification for Medical Device and Quality Management Systems (QMS). ISO 13485 is an internationally recognized set of quality management system requirements for medical devices. To be certified, a company must demonstrate the ability to provide products that consistently meets customer and regulatory requirements. Companies which are ISO 13485 certified are audited annually and must recertify every 3 years. Many countries require certification to ISO 13485 to sell medical devices in their country.
The audit to recertify Altimate’s QMS and expand its scope to include the functions of the former ActiveAid business took place in early February. Official certification was received in this week culminating the end of the 3 ½ year project for Altimate. “ISO 13485:2016 is the most internationally recognized quality system standard and Altimate’s certification demonstrates we comply with the laws and regulations of the medical device industry” said Amy Curtis, Director, Quality and Regulatory for Altimate Holdings. “It took effort and dedication from each team within the company to make this happen and involves nearly every aspect of the business: management, resources, design, manufacturing, assembly, customer service, procurement, and more.”
“In 2018 when Altimate Medical purchased Activeaid, one of the goals it set for the newly acquired company was to become certified to the ISO 13485 standard for Medical Devices.”
said Paul Hickey, President and CEO for Altimate Holdings. “We want to thank our employees for their efforts in making this transition a success and look forward to celebrating this accomplishment with them. Their achievement aligns with our unwavering commitment to quality and our mission to help improve lives with the products we make every day.“
Altimate Medical Holdings, Inc. designs and manufactures differentiated medical equipment that optimizes treatment outcomes and maximizes the health and wellbeing of the end-users. Since its founding in 1987, Altimate Medical and its EasyStand brand has led the standing industry with unsurpassed technology. Altimate Medical has since expanded its product portfolio and made several acquisitions of well-known and respected brands within the complex rehab technology market (Zing, 2015; ActiveAid, 2018) and the healthcare capital equipment market (Medical Positioning, Inc., 2015). The Altimate Medical family of brands include: ActiveAid, EasyStand, Justify It, Zing, Medical Positioning, VizaVue®, EchoBed®, UltraScan Versa™, and UltraDBI™.