Yverdon-les-Bains, Switzerland. - Symbios is proud to announce that the company was granted the CE certificate under the European regulation EU-MDR 2017/745 for the ORIGIN® PS/CR knee system. The certificate was granted by the notified body mdc GmbH (Stuttgart, Germany) as well as the ISO-13485:2016 that ensures that Symbios’ Quality Management System is fully compliant to ISO and EU-MDR standards for medical devices.
The ORIGIN® knee system is an individualized total knee replacement system that intends to restore each individual’s knee alignment, shape and kinematics to improve patients’ satisfaction and clinical outcomes.
“This first EU-MDR CE certificate is the result of the unconditional commitment of Symbios and all its employees to surpass themselves to comply with the European regulations – which are amongst the strictest in the world – as well as to deliver safe and high-performance devices to patients benefiting from our individualized products” commented Florent Plé, President & CEO of Symbios. “This substantial milestone rewards years of hard work achieved by highly skilled and talented people that went the extra mile day after day stubbornly, as well as massive financial investments to ensure that Symbios becomes a leading company in the orthopaedic landscape in the coming years. We all are very proud of this result today!”
“I am proud, very satisfied and delighted for our first product having been granted the EU-MDR certificates. This success is without any doubt another demonstration of Symbios’ commitment to become a leader in our industry” added Nicolas Guignet, Vice President Quality and Regulatory Affairs at Symbios. “This was a long journey to get there and it represents an enormous investment of the organization. Thanks to all employees for this great achievement. We are on regular contact with our EU-MDR notified body and I am confident that the rest of Symbios’ portfolio will be certified in the coming months.”