Latest medtech regulatory news

ISO 9001:2015 and ISO 1345:2016 Certifications

New Scale Technologies Inc. achieved ISO 9001:2015 and ISO 13485:2016 certifications for its quality management systems related to medical devices.

ISO 9001:2015 provides a model for building effective quality management systems based on core quality management principles. ISO 13485:2016 additionally specifies requirements needed to deliver medical devices and related services consistently meeting customer and applicable regulatory requirements.

The certificates were issued following extensive analysis of the company’s quality management systems by independent auditing firm Eagle Registrations Inc.

FDA clearance for fixation system

Spine and orthopedics focused Orthofix received U.S. Food and Drug Administration (FDA) 510(k) clearance for its TrueLok EVO ring fixation system. Designed for complex limb reconstruction and deformity correction procedures, TrueLok EVO is the only circular fixator featuring both radiolucent rings and struts to enable clear radiographic visualization, allowing physicians to better assess bone anatomy during surgery and post-operative care. It’s also the first circular external fixation kit available as a pre-assembled frame in ready-to-use single use sterile packaging.

Dedicated support for EU MDR regulated customers

Norman Noble Inc., a contract manufacturer of next-generation medical implants, added staff to its quality team to support customers supplying the European market, meeting the new European Union Medical Device Regulation (EU MDR) requirements, such as chemical reporting and conflict mineral reporting.

Formal Documentation of Medical Device and Medical Device Component cleanliness is critical to customers’ regulatory compliance and new product approval needs. In response, Noman Noble operates and maintains a final cleaning process validated in accordance with ASTM F3127-16 in addition to select customer product cleanliness requirements.