Quantum Surgical, an innovative surgical robotics company, today announced that it has obtained ISO 13485: 2016 certification for the “Design & development of computer assisted surgical systems” by The Certification Body of TUV Rheinland.
This internationally recognized certification confirms that the quality management system meets the specific standards required for the design and development of Quantum’s technology.
“Obtaining ISO 13485: 2016 certification is an important step for Quantum Surgical. It is an essential instrument to meet regulatory requirements and shows the company’s determination to be part of an industrial approach that meets the highest standards of safety, performance and reliability” explains Bertin Nahum, CEO and co-founder of Quantum Surgical.
What is the ISO 13485: 2016 standard?
The ISO 13485: 2016 standard, recognized worldwide, specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Quantum Surgical in a few words
Co-founded in 2017 by Bertin Nahum, Quantum Surgical is an innovative Robotic Surgery Start-up company based in France’s Montpellier region that is aiming is to conceive an innovative solution; a combination of powerful software and robotic platform for minimally invasive therapies in liver cancer. This platform combining robotics, image analytics and artificial intelligence will allow more and more patients to benefit from safer interventional oncology procedures, especially in the case of early-stage liver cancers. The incidence of liver cancer in the population is unfortunately growing very rapidly. It is one of the most common cancers with more than 8000 new cases each year in France and 800 000 cases in the world
Further information is available on our website: https://quantumsurgical.com/