Press Release: Ximedica’s West Coast Locations Receive Confirmation of ISO 13485:2016 Certifications
Oct 15, 2018
Providence, RI - Ximedica announced today that the organization’s West Coast locations (San Francisco and Silicon Valley) are now registered to ISO 13485:2016, receiving confirmation of their certifications in September 2018.
According to the International Organization for Standardization, ISO 13485:2016 “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.” Organizations like Ximedica who seek ISO 13485 certification are often involved in the full medical product life-cycle, including design and development, and manufacturing of a medical device.
“At Ximedica, we take pride in helping our clients develop high quality medical and in vitro diagnostic technologies. To do so, we have a well-established, flexible, yet appropriately risk‑based quality management system,” said Michelle Wu, Ximedica’s Vice President of Quality. “The addition of the San Francisco and Silicon Valley offices to our ISO 13485 certificate is a great achievement and expands the number of certified sites we have to offer our design and development services.”
“This is a significant accomplishment for Ximedica,” Robert Brown, Ximedica’s newly appointed CEO, said. “In addition to successfully adding on our two California sites to our ISO certificate, Ximedica has successfully expanded our quality management system to meet the ISO 13485:2016 revision. We now have 4 sites certified to ISO 13485:2016: Providence, Minnesota, San Francisco, and Silicon Valley. For over thirty years, Ximedica has consistently delivered innovative products and consulting services to their clients in the medical industry while also delivering devices that are safe for their intended purpose. Effectively certifying all four locations in the U.S. only enhances the breadth and depth of Ximedica’s capabilities.
Ximedica is a full-service ISO 13485-certified and FDA-registered medical device and diagnostics product development firm. For 30 years Ximedica has provided a unique growth platform enabling organizations to successfully deploy medical technology products into the market. Its headquarters are in Providence, R.I., with offices in Hong Kong, Minneapolis, San Francisco and Silicon Valley. In November of 2014, SV LifeSciences, a Boston-based private equity firm, acquired a majority stake in Ximedica, enabling the company to execute its growth strategy. For more about Ximedica, visit http://www.ximedica.com/.