Amnovis achieves ISO 13485 certification supported by software partner Oqton

September 28, 2021

Amnovis has achieved ISO 13485 certification for its quality management standards supported by its software partner Oqton (Courtesy Oqton)

Additive Manufacturing company Amnovis, Aarschot, Belgium, has achieved ISO 13485 certification for meeting internationally recognised quality management standards supported by its software partner Oqton, San Francisco, California, USA. The certification is said to support the company’s strategic focus on high-end, quality-critical applications, including medical devices.

Founded in June 2020 by Peter Mercelis and Ruben Wauthle, Amnovis uses innovative AM technologies and materials for high-end applications such as medical devices. The company’s founders have over a decade of experience in using AM to make high-end products and were reportedly among the early adopters of Laser Beam Powder Bed Fusion (PBF-LB) to produce additively manufactured titanium medical devices, such as orthopaedic and spinal implants. With this industry experience, Mercelis and Wauthle are aiming to pave 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,” stated Ruben Wauthle, CEO and co-founder.

Mercelis and Wauthle identified Oqton as its partner to deliver the key role that the right manufacturing software platform would play in achieving their goals for Amnovis. Oqton is a global SaaS (Software as a Service) company founded in 2017 by experts in the field of manufacturing and AI. The Oqton MOS platform provides scalable, sustainable, and efficient manufacturing for companies of any size.

“We were immediately convinced by the possibilities of Oqton as the single source of truth for all our manufacturing activities,” Wauthle continued. “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 digitise our production and automate as many steps as possible of the production process.”

Ben Schrauwen, Oqton CEO, commented, “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.”

In the latest issue of Metal AM magazine

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

  • Metal powders in Additive Manufacturing: An exploration of sustainable production, usage and recycling
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  • Consolidation, competition, and the cost of certification: Insight from New York’s AM Strategies 2024
  • Scandium’s impact on the Additive Manufacturing of aluminium alloys
  • AM for medical implants: An analysis of the impact of powder reuse in Powder Bed Fusion

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