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Quantum Surgical obtains ISO 13485: 2016 certification

Published on
November 28, 2019
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Montpellier,November 28, 2019 - 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 TheCertification Body of TUV Rheinland.

This internationallyrecognized certification confirms that the quality management system meets thespecific standards required for the design and development of Quantum'stechnology.

"ObtainingISO 13485: 2016 certification is an important step for Quantum Surgical. It isan essential instrument to meet regulatory requirements and shows the company’sdetermination to be part of an industrial approach that meets the higheststandards of safety, performance and reliability” explains Bertin Nahum, CEOand co-founder of Quantum Surgical.

What isthe ISO 13485: 2016 standard?

The ISO13485: 2016 standard, recognized worldwide, specifies requirements for aquality management system where an organization needs to demonstrate itsability to provide medical devices and related services that consistently meetcustomer and applicable regulatory requirements. Such organizations can beinvolved in one or more stages of the life cycle, including design anddevelopment, production, storage and distribution, installation, or servicingof a medical device and design and development or provision of associatedactivities (e.g. technical support). ISO 13485:2016 can also be used bysuppliers or external parties that provide product, including qualitymanagement system-related services to such organizations.

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