Standards
Airway Management, a developer of advanced oral appliances, has achieved FDA clearance for its Nylon flexTAP, one of the first digitally printed single-point midline oral appliance devices for sleep apnea.…
ASTM International’s additive manufacturing technologies committee (F42) has approved a new standard, F3774, that aims to assist all who use AM in a business-case capacity, whether it be a manufacturer,…
ASTM International’s additive manufacturing technologies committee (F42) is developing a proposed standard (WK80171) that will offer guidance on selecting suitable techniques for detecting, quantifying, and classifying contamination that may be…
INNOSPACE, a South Korean satellite launch service company heavily reliant on additive manufacturing, has been awarded the ISO 37301 certification for its compliance management system (CMS), the globally recognized standard…
Cairn Surgical, an innovative medical technology firm striving to make breast cancer surgery more precise, has received ISO 13485:2016 certification for its Quality Management System associated with the novel 3D…
Founded a decade ago, the 3MF Consortium set out to establish a full-fidelity file format for 3D printing that solved issues related to other commonly used file formats like STL.…
Stryker, a medical technologies company, has received US Food and Drug Administration (FDA) 510(k) clearance for the Incompass Total Ankle System, an implant intended for patients with ankle joints damaged…
ASTM International’s additive manufacturing committee (F42) is developing a proposed standard (WK94968) that will help to define the printability range of cementitious materials for any given extrusion-based 3D printer. WK94968 is under development within the committee’s test…
ASTM International’s Additive Manufacturing Center of Excellence (AM CoE) introduced a new manufacturer certification program crafted to bolster quality assurance, streamline regulatory compliance, and enforce rigorous process control across AM…
ASTM International’s Additive Manufacturing Center of Excellence (AM CoE) has launched a new manufacturer certification program designed to enhance quality assurance, regulatory compliance, and process control across the additive manufacturing…
