Amnovis obtains ISO 13485 certification for innovative additive manufacturing processes supported by Oqton
Additive manufacturing company and Flam3D-member Amnovis has achieved ISO 13485 certification for meeting demanding, internationally agreed quality management standards. The certification will support the company’s strategic focus on high-end, quality-critical applications, including medical devices.
Amnovis’ founders have a proven track record, going back to 2008, in using additive manufacturing (AM) to make high-end products, and were among the pioneers to employ L-PFB for printing titanium medical devices, such as orthopedic and spinal implants. They are now using that experience and know-how to do things even better and faster, paving the way for the use of emerging AM technologies and materials in regulated and high-tech industries. “At Amnovis, we believe the full potential of AM can be unlocked through thoughtful innovations. So, we are continuously looking for technical challenges and opportunities to redefine the state-of-the-art in AM,” says Ruben Wauthle, CEO and one of the company’s founders.
Even before setting up the company, Wauthle and co-founder Peter Mercelis identified the key role that the right manufacturing software platform would play in achieving their goals. And that’s how they ended up with Oqton as a partner. “We were immediately convinced by the possibilities of Oqton as the single source of truth for all our manufacturing activities,” explains Wauthle.
“Oqton combines all the functionalities that we need to produce high-end products, including full traceability of all production steps and materials from powder to finished part. It supports our vision to fully digitize our production and automate as many steps as possible of the production process.”
Amnovis has now achieved ISO 13485:2016 certification from SGS for the quality management system it has built, relying on Oqton as its manufacturing execution system (MES). “We have worked closely with the Oqton team to get the Oqton platform validated for our intended use,” adds Wauthle. “We were impressed with the power of the Oqton software and its architecture.”
Oqton is equally proud to partner with Amnovis. Pointing to the key benefits this partnership delivers for clients – especially in the medical sector – Oqton CEO Ben Schrauwen says: “The medical production environment experiences an increasing need for speed and flexibility, while at the same time the regulation gets stricter. This stresses the need for a comprehensive workflow and production platform driving operational excellence and providing full traceability and repeatability. AI and machine learning eliminate certain repetitive tasks, leaving the experts with more time for value added work.”