Restoration Robotics has completed its ISO 13485:2016 audit and is compliant with CE Mark requirements for the sale of the ARTAS iX system with implantation in Europe.


Image: Restoration Robotics secures ISO certification. Photo: Courtesy of Franck V./Unsplash

The Company shipped the first ARTAS iX Systems to customers in Europe in last December.

Restoration Robotics president and CEO Ryan Rhodes said: “This certification and our first shipments of the ARTAS iX System to customers in Europe further validate our technology and represent two critical milestones ahead of final CE Mark approval.

“We look forward to further expanding access to our cutting-edge robotic hair restoration technology with implantation functionality while driving system sales globally.”

The International Organization of Standards (ISO) is a non-government entity comprised of academic and industry professionals that certifies that companies are compliant with industry-standard best practices in their production and operations.

Specifically, ISO 13485:2016 is an internationally recognized quality standard for a quality system to ensure customer and regulatory requirements are consistently met throughout the lifecycle of the medical device product.

Source: Company Press Release