For its new facility in San Leandro, California, Nanomix Corporation, a pioneer in portable, cost-effective point-of-care diagnostics, has acquired ISO 13485 certification.
In April 2022, Nanomix started the move to its new manufacturing plant. The new facility, which is 9327 square feet, can house the growing workforce of the company. Additional automation is part of the facility investment that boosts capacity right away and provides great flexibility for demand-driven expansion of the tests and patented multiplex cartridge technology from Nanomix.
The ISO 13485 certification verifies and affirms the robust quality system that Nanomix has in place, according to Vidur Sahney, Chief Operating Officer of Nanomix. This is also a significant accomplishment and the outcome of a smooth transition of our manufacturing technologies to our new plant. To satisfy consumer demand for the eLab S1 critical infection panel and other upcoming products, we are continuing and speeding up our manufacturing scaling as a result of this ISO accreditation.
The objective of ISO 13485:2016, a widely accepted quality standard, is to guarantee that medical devices and related services are consistently designed, developed, produced, and sold in accordance with their intended uses. Organizations must prove that their Quality Management Systems can consistently deliver goods and services that satisfy customers and any applicable legal requirements in order to be certified.
According to the federal securities laws, a few comments in this press release are “forward-looking statements.” Forward-looking statements cover, among other things, the company’s intentions, beliefs, projections, outlook, analyses, or current expectations with regard to its ongoing and planned product development, its intellectual property position, its capacity to develop commercial functions, its expectations for the launch and sale of its products, its operational outcomes, cash requirements, spending, financial condition, liquidity, and other future events. Actual outcomes could substantially differ from those projected in these forward-looking statements as a consequence of a number of significant factors
