Amnovis obtains ISO 13485 certification for
innovative additive manufacturing processes
Aarschot, Belgium, September 27th, 2021.
Additive manufacturing trailblazer 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 quality management system would play in achieving their goals. “One of our core values is to commit to quality. Put simply, this means we don’t compromise the standards we set, no matter what,” explains Wauthle.
“With all the innovative AM processes we want to add to our capabilities, it was crucial for us that we built a flexible and scalable quality management system that allows us to easily introduce new AM technologies and materials that have been validated by our experienced team. Therefore, we are proud to have established a 100% digital quality management and manufacturing execution system.”
Amnovis has now achieved ISO 13485:2016 certification from SGS Belgium for the quality management system it has built, currently offering best in class metal powder bed fusion and post-processing. “Later this year, we will already add another AM technology, specifically for medical device manufacturing. ” adds Wauthle. “We are very excited about what the future brings for our company, customers and partners, as we will continue to enable innovations in additive manufacturing.”
Founded in June 2020 by Peter Mercelis and Ruben Wauthle and based in Aarschot, Belgium, Amnovis is a manufacturing and engineering company that uses innovative additive manufacturing technologies and materials for high-end applications such as medical devices. As an ISO 13485 certified contract manufacturer, Amnovis offers best in class metal powder bed fusion and post-processing, and paves the way for emerging AM technologies and materials. Whichever technology and material fit the application: conforming parts, on time, that’s what Amnovis’ production is all about.
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