Newsroom - Tekna
TEKNA’s Advanced Materials division meets the highest global standards for medical products.
Tekna (OSE: TEKNA), a world-leading provider of advanced materials and plasma systems is pleased to announce that the company’s Advanced Materials division has renewed its ISO 13485:2016 certificate.
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Originally obtained in 2022, the certification establishes that the processes Tekna Advanced Materials uses to manufacture its commercial powders meet the highest global standards for medical products.
The ISO 13485:2016 certification is an international standard that stipulates the requirements for a quality management system specific to the medical devices industry. The certification ensures alignment with quality management system practices, including changes in technology and regulatory requirements and expectations.
The recertification audit was conducted by NQA and took one week. It included Tekna’s manufacturing site, HR practices, purchasing procedures, equipment maintenance, and laboratory. The renewal is valid until January 2029.
“We are proud to announce the renewal of our ISO 13485 certification, reaffirming our commitment to the highest standards of quality, regulatory compliance, and patient safety. This achievement reflects the strength of our quality management system and the dedication of our team to continuous improvement," says Tekna CEO, Claude Jean.
“Arendals Fossekompani is pleased to see this certification renewed, though we are not surprised. Throughout our 12 years of active ownership, Tekna has consistently demonstrated world-class practices, strong commitment, and outstanding product quality. Congratulations to the entire team on this well-deserved achievement.”
Ann-Kari Heier, Executive Vice President at Arendals Fossekompani
Benefits in the field
The combination of additive manufacturing technologies and Tekna powders provides significant innovations and improvements in the medical industry. Tekna’s Advanced Materials division produces Ti64 powder that is mostly used to 3D print cranial and hip implants in the medical field. One of the biggest benefits is the improved precision which allows for a more customized prosthesis produced in shorter lead times.
About TEKNA:
Tekna is a world-leading provider of advanced materials and plasma systems to several industries. Tekna produces high-purity metal powders for applications such as 3D printing in the aerospace & defence, medical and consumer electronics sectors, as well as optimized induction plasma systems for industrial research and production.
AFK Ownership: 69.5%
Employees: 174
Head Office: Sherbrooke, Canada
Global megatrends: Tekna is positioned at the intersection of advanced materials and manufacturing, industrial digitalisation, aerospace and space technologies, sustainable production, and health/medical innovation.
