Sirius Medical Announces ISO-13485:2016 Certification

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by Sirius Medical
Today, Sirius Medical proudly announces that it has received ISO 13485:2016 certification for its Quality Management System (QMS) following review by its notified body, DEKRA.

ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry and signifies Sirius Medical’s commitment to the highest level of medical device quality controls and meeting customer and international regulatory expectations as we prepare for commercialization.

Sirius Pintuition is a next-generation localization system. At Sirius, we foresee a future where surgical treatment of early-stage cancer relies on our proprietary non-radioactive, point-source localization technique. Sirius Pintuition provides directional and intuitive localization with millimeter accurate real-time distance feedback. The Pintuition Probe is reusable, robust and very simple to use. Sirius Pintuition will provide access to the benefits of radioactive seeds without any of its safety concerns.

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