Relu Wins ISO Certification for Medical Device

Relu obtained ISO13485 certification from EU Notified Body Kiwa Dare.

Image Credits: Relu

Relu, an OEM software provider in the dental industry, obtains ISO13485 certification from EU Notified Body Kiwa Dare. ISO13485 is the global quality standard for medical device companies.

Relu provides enterprise-grade 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 ISO13485 certification will further increase the quality of Relu's product, besides reducing the regulatory work of their partners when integrating AI in their medical device software. Relu takes this step to bring better AI innovation to both the dentist and the patient, according to a press release.

"This certification demonstrates our commitment to international quality and regulatory standards. Relu wants to build AI that people can trust," says Holger Willems, Co-Founder & CEO at Relu.

Read more: AI-Powered Wheeze Detector Receives FDA Clearance

"We've achieved ISO13485, underscoring our commitment to quality and safety. 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." says Bindu Saran, Director at Relu and Former Global Head of Orthodontic Technology at Straumann Group.

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. They recently got investment from industry veterans like Dental Innovation Alliance. Relu is situated in Leuven, Belgium. Learn more at

About ISO1348

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.

Sam Draper
September 15, 2023

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