19 September 2023

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Relu obtains global quality standard for medical device companies

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Relu, an OEM software provider in the dental industry, obtained ISO13485 certification from EU Notified Body Kiwa Dare. ISO13485 is the global quality standard for medical device companies, according to a Sept. 12 news release.

The company provides enterprise-grade artificial intelligence (AI) for workflow automation in dental treatment software. They partner closely with leading dental software companies to make their software more valuable and user-friendly with AI.

This new certification will help to increase the quality of Relu's product, and it will also reduce the regulatory work of partners when integrating AI in their medical device software. Relu took this step to bring better AI innovation to both the dentist and the patient.

"This certification demonstrates our commitment to international quality and regulatory standards," said Holger Willems, co-founder & CEO at Relu in the news release. He added that the company wants to build AI that people can trust.

"We've achieved ISO13485, underscoring our commitment to quality and safety," said Bindu Saran, director at Relu and former global head of orthodontic technology at Straumann Group. "This certification reassures our global partners of our dedication to innovative AI solutions for implantology and orthodontics. It's a clear mark of trust for all involved."

About Relu

Founded in 2019, Relu has grown to a 15-person team with a vision to make dental treatments safer, faster and better with AI. They partner with the biggest companies in dentistry to embed Relu's AI plug-in into the leading dental treatment software. The company recently landed investments from industry veterans like Dental Innovation Alliance. Relu is based in Leuven, Belgium. Learn more at www.relu.eu.

About ISO13485

The ISO 13485:2016 is an international standard required to sell medical devices in many countries. It specifies the requirements for a medical quality management system. Learn more about the standard at www.iso.org/standard/59752.html.