Apex Additive Technologies gains ISO 13485 certification for medical AM
Apex Additive Technologies, Ebbw Vale, Wales, UK, has announced that it is now certified to ISO 13485, following the development, documentation and audit of a quality management system for highly regulated medical contract manufacturing.
ISO 13485 is the internationally recognised standard for quality management systems in the design and manufacture of medical devices.
“Our team has built, documented and proven a quality management system fit for heavily regulated medical contract manufacturing,” stated Youssef Gaber, CEO at Apex Additive Technologies, in a LinkedIn post. “Not just by meeting the minimum requirements, and not by acting as an intermediary, but by controlling every process end to end. One site. One register. One evidence trail.”
Each manufacturing stage is recorded, from the Laser Beam Powder Bed Fusion (PBF-LB) Additive Manufacturing through to finishing. “Full, transparent traceability from powder to dispatch. In-house CT inspection to verify material quality and validate contamination control. An evidence trail behind every single component. Nothing left to chance,” added Gaber.
In the announcement, Gaber expressed pride in the work of the Apex team and thanked Jono Munday and Bozena Wood for their contributions, alongside the company’s partners and suppliers.
