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

Metal AM magazine Summer 2022

In the latest issue of Metal AM magazine

Download PDF
 

Extensive AM industry news coverage, as well as the following exclusive deep-dive articles:

  • Transforming access to medical implants with PrinterPrezz
  • Lessons from 2021’s Olympic bike crash
  • Xerox liquid metal AM
  • Additive Manufacturing for oil, gas and maritime
  • Multi-material metal parts by Powder Bed Fusion
  • Findings from Wohlers Report 2022
  • The challenge of grain size: X-ray powder diffraction analysis of parts made by metal AM

The world of metal AM to your inbox

Don't miss any new issue of Metal AM magazine, and get the latest industry news. Sign up to our twice weekly newsletter.

Sign up

News from the industry…

    News from the industry…

    Discover our magazine archive…

    The free to access Metal Additive Manufacturing magazine archive offers unparalleled insight into the world of metal Additive Manufacturing from a commercial and technological perspective through:

    • Reports on visits to leading metal AM part 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

    qweqw

    Looking for AM machines, metal powders or part manufacturing services?

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

    • AM machines
    • Process monitoring & calibration
    • Heat treatment & sintering
    • HIP systems & services
    • Pre- & post-processing technology
    • Powders, powder production and analysis
    • Part manufacturers
    • Consulting, training & market data
    Download PDF
    Share via
    Copy link
    Powered by Social Snap