7.3.2022 09:00:00 CET | Tekna Holding AS | Non-regulatory press releases
ARENDAL, NO / SHERBROOKE, QC. 7 March 2022 – Tekna (OSE: TEKNA), the world-leading provider of advanced materials to industry, today announced that the company’s Advanced Materials division has achieved ISO 13485:2016. The certification establishes that the processes Tekna Advanced Materials uses to manufacture its commercial powders meet the highest global standards for medical products.
ISO 13485:2016 Certification is an internationally agreed standard that stipulates the requirements for a quality management system specific to the medical devices industry. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The certification process took approximately a year, and included the audit of Tekna’s manufacturing site, HR practices, purchasing procedures, equipment maintenance and laboratory. The audit was conducted by Intertek Group Plc- 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,” said Tekna CEO Luc Dionne. “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 organization.”
Material sales to the medical sector represented 10% of Additive Manufacturing’s total material sales in the fourth quarter of 2021 and the growth rates 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,” said Dionne.
Tekna is also in the process of obtaining ISO 17025 Certification for its testing laboratory in order to prepare for Nadcap certification later this year.
Disclosure regulation
This information is subject to the disclosure requirements pursuant to Section 5-12 of the Norwegian Securities Trading Act.
Contacts
Arina van Oost, Investor Relations | VP Corporate Strategic Development & Innovation, +1 438 885 6330, Investors@tekna.com
About Tekna Holding AS
Tekna is a world-leading provider of advanced materials to industry, headquartered in Sherbrooke, Canada. Tekna produces high-purity metal powders for applications such as 3D printing in the aerospace, medical and automotive sectors, as well as optimized induction plasma systems for industrial research and production. With its unique, IP-protected plasma technology, the company is well positioned in the growing market for advanced nanomaterials within the electronics and batteries industries. Building on 30 years of delivering excellence, Tekna is a global player recognized for its quality products and its commitment to its large base of multinational blue-chip customers.
www.tekna.com
Attachments
Download announcement as PDF.pdf
Tekna ISO13485 certificate.pdf
