The UK’s LPW Technology has recently added ISO 13485 certification for medical supply to its existing quality control standards, AS 9100 and AS 9120 for aerospace, and ISO 9001.
LPW states that it is committed to the development and supply of metal powders that meet the requirements of users of Additive Manufacturing (AM) machines. This standard certifies that LPW has established a quality management system that demonstrates its ability to meet the stringent requirements of customers in the biomedical technology and device market.
“Achieving ISO 13485 means it will be easier for our customers to go through their regulatory supplier approvals when bringing a medical or dental application to market which incorporates powders from LPW,” stated Managing Director Dr Phil Carroll. “Although as the raw material [metal powders] being supplied to our customers is classed as a component part, and the CE mark directive is only relevant to finished products, we believe ISO 13485 certification gives new and existing customers the reassurance they need in the consistency of our quality management system and the powders we supply.”
The properties of the metal powders used directly impact the reliability of the performance of the AM process and, crucially, the mechanical properties of the finished component. The certification ensures best practices and continuous assessment including the company’s development, manufacture, and testing capabilities critical to quality and traceability during all stages of a powders lifecycle, leading to a safer device whether in clinical or research applications.