Intuitive Surgical Receives ISO 13485 Certification
Intuitive Surgical, Inc. has confirmed its quality management system conforms to the ISO 13485:2016 standard. The certificate covers the design, manufacture, and service of its surgical systems.
Intuitive Surgical, Inc., a U.S.-based medical device manufacturer, has received official certification confirming its quality management system adheres to the ISO 13485:2016 / EN ISO 13485:2016 standard. The certificate was issued by DNV Product Assurance AS and is valid until December 16, 2027.
The certification scope encompasses the design, manufacture, service, and installation of the company's computer-controlled surgical systems, surgical generators, and instruments. This also includes the production of endoscopes, surgical instruments, sterile drapes, and accessories used with these systems.
Furthermore, the certification covers the design and manufacture of the Ion Endoluminal System, which includes articulating catheters, vision probes, biopsy needles, planning software, and associated accessories. The company also designs and manufactures staples and stapling systems.
Multiple Intuitive Surgical facilities across the United States, Mexico, Germany, and Switzerland are included under this certification. This recognition underscores the company's commitment to maintaining high-quality standards in the production of medical technology.