Altimate Medical receives certification
By HME News Staff
Updated 9:53 AM CDT, Tue April 5, 2022
REDWOOD FALLS, Minn. – Altimate Medical, maker of the EasyStand, has received ISO 13485:2016 certification for Medical Device and Quality Management Systems (QMS). 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. “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.” Altimate Medical purchased ActiveAid in 2018, with the goal of certifying the company. 13485:2016 certification is an internationally recognized set of quality management system requirements for medical devices. To be certified, companies must demonstrate the ability to provide products that consistently meet customer and regulatory requirements. Companies that are certified are audited annually and must recertify every three years. Many countries require certification to sell medical devices in their country.
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