We’re pleased to announce our upgraded certification to the 2016 revision of ISO 13485. Our quality management system is a vital part of our commitment not only to our medical device customers, but also to the patients, physicians, and regulators around the globe who read our translations. In addition to ISO 13485:2016, our quality management system is certified to ISO 9001:2015 and ISO 17100:2015.
ISO 13485, the international standard for quality management system requirements for medical devices, helps organizations to establish reliable processes that reduce the risk of defect or error. Key elements of the 2016 revision revolve around improved supplier controls and deeper process validations.
Read our full press release here.