Osseus Fusion Systems receives ISO 13485:2016 certification

April 23, 2020

Osseus Fusion Systems, Dallas, Texas, USA, reports that it has received ISO 13485:2016 certification with the Medical Device Single Audit Program (MDSAP), part of the U.S. Food and Drug Administration (FDA), which will reportedly allow the company to accelerate growth of its spinal fusion and fixation products in international markets. 

Osseus is a medical device company specialising in advanced technology products for minimally invasive surgery. According to The International Organization for Standardization, ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Derek Holland, Vice President of Sales, Osseus Fusion Systems, commented, “We are excited to announce this ISO certification milestone and feel it exemplifies our drive for an impeccable level of quality and compliance. Additionally, with demand that already exists, we now have the opportunity to pursue international supply chains that give us incredible growth potential.”

www.osseus.com

www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

In the latest issue of Metal AM magazine

Download PDF
 

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

  • Back to the future: A decade of Additive Manufacturing innovation and growth at Materials Solutions
  • Win or lose: A CEO’s reflections on Artificial Intelligence and Additive Manufacturing
  • AMS 2025 New York: A reality check for the Additive Manufacturing industry
  • Optimising powder removal in PBF-LB Additive Manufacturing: A Digital Twin approach
  • ValCUN’s MMD: A robust, wire-based aluminium AM technology for defence and industrial applications
  • Enhancing quality and reliability in metal Additive Manufacturing: The role of laser calibration

Join 40,000+ other AM professionals – follow us online

Don’t miss a thing – register for our newsletter

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

Register now

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
Find suppliers

About Metal Additive Manufacturing magazine

Metal AM magazine, published quarterly in digital and print formats, is read by a rapidly expanding international audience.

Our audience includes component manufacturers, end-users, materials and equipment suppliers, analysts, researchers and more.

In addition to providing extensive industry news coverage, Metal AM magazine is known for exclusive, in-depth articles and technical reports.

Our focus is the entire metal AM process from design to application.

Each issue is available as an easy-to-navigate digital edition and a high-quality print publication.

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

Share via
Copy link
Powered by Social Snap