Tekna Holding AS, Sherbrooke, Quebec, Canada, has announced that its Advanced Materials division has achieved ISO 13485:2016 certification. This certification is an internationally agreed standard that outlines the requirements for a quality management system specific to the medical devices industry.
The certification process took approximately a year and involved an audit of the company’s manufacturing site by Intertek Group Plc, HR practices, purchasing procedures, equipment maintenance and laboratory. The certification is valid until February 2025.
“This marks a milestone in Tekna Additive Manufacturing’s advancement in the medical market, securing our position within the global medical supply chain as a supplier of safe, high-quality powders for medical devices, such as implants and X-ray collimators,” stated Luc Dionne, CEO, Tekna. “We’re very proud of our team for successfully completing the rigorous process to receive ISO 13485:2016. This designation is a testament to the high standards and commitment to quality all the way through the Tekna organisation.”
Material sales to the medical sector were said to have represented 10% of the total material sales of Additive Manufacturing in the fourth quarter of 2021, and the growth rates are forecast to accelerate in 2022.
“We see that the medical sector is steadily recovering from the COVID-19 pandemic. It is an important industrial sector for Tekna and we expect the ISO 13485 Certification to accelerate our market penetration by facilitating our product qualification, providing further momentum in a favourable market environment,” Dionne added.
Currently, Tekna is in the process of obtaining ISO 17025 Certification for its testing laboratory in order to prepare for Nadcap certification later this year.