Tekna Advanced Materials achieves ISO 13485 certification

March 7, 2022

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.

www.tekna.com

Recent issue of Powder Metallurgy review - your go-to resource to stay updated on the world of powder metallurgy and metal powders

In the latest issue of PM Review…

PM Review Spring 2023

Download PDF

Extensive Powder Metallurgy industry news coverage, and the following exclusive deep-dive articles and reports:

  • GKN Powder Metallurgy: A strategic vision for the future of permanent magnets for EVs
  • Building trust in the Powder Metallurgy industry: The role of standardisation and an update on recent work by ISO/TC 119
  • High-volume powder production for Additive Manufacturing: SMS group’s continuous metal powder production process
  • Development of enhanced-performance PM brake pads for high-speed trains by Beijing Tianyishangjia New Material Corp., Ltd.
  • The START project: Creating a sustainable supply chain for green energy harvesting products by Powder Metallurgy
  • World PM2022: Reviewing three innovative methods for metal powder production

The latest news from the world of metal powders, delivered to your inbox

Don't miss any new issue of PM Review, and get the latest industry news. Sign up to our weekly newsletter.

Sign up

Join our community

From the industry…

Discover our magazine archive…

The free-to-access PM Review magazine archive offers unparalleled insight into the world of Powder Metallurgy from a commercial and technological perspective through:

  • Reports on visits to leading PM part manufacturers, metal powder manufacturers and industry suppliers
  • Articles on technology and application trends
  • Information on materials developments
  • Reviews of key technical presentations from the international conference circuit
  • International industry news

All past issues are available to download as free PDFs or view in your browser.

 

Browse the archive

 

Looking for PM production equipment, metal powders, R&D support and more?

Discover suppliers of these and more in our
advertisers’ index and buyer’s guide, available in the back of PM Review magazine.

  • Powders & materials
  • Powder process, classification & analysis
  • PM products
  • Atomisers & powder production technology
  • Compaction presses, tooling & ancillaries
  • Sintering equipment & ancillaries
  • Post-processing
  • Consulting & toll sintering
Download PDF
Share via
Copy link