Mesa Biotech Receives ISO 13485 Quality Certification
SAN DIEGO – May 23, 2017 – Mesa Biotech Inc., a privately held, molecular diagnostic company that has developed a molecular testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced that it has received an internationally recognized ISO quality certification. This designation marks the completion of a critical step for the commercialization of Mesa Biotech’s novel Accula™ System in the European Union (EU) and the United States (US).
The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. ISO 13485:2003 specifies the requirements for quality that an organization needs to demonstrate to provide medical devices and related services that consistently meet customer and regulatory requirements. This certification is a critical path precursor to the commercialization of medical devices in the EU.
“Achieving ISO certification demonstrates that Mesa Biotech has successfully implemented a quality management system that conforms to the world-wide standard for medical device and in vitro diagnostic manufacturing,” said Hong Cai, co-founder and CEO of Mesa Biotech. “This is an important milestone for the company as we prepare for commercialization of our Accula System in the EU and US. It is also a testament to our commitment to quality across all functions of the business, from design and development to manufacturing and supply.”
About Mesa Biotech Inc.
Mesa Biotech is an emerging molecular diagnostic company, bringing the superior diagnostic performance of nucleic acid amplification to the point-of-care (POC). Mesa Biotech’s Accula™ System consists of a portable, palm-sized dock and a disposable, assay-specific test cassette. This patented system will allow healthcare professionals to access actionable, laboratory-quality results at the POC in 30 minutes or less with greater sensitivity and specificity than many current infectious disease rapid immunodiagnostic tests. Mesa Biotech’s technology development has been funded to date by a series of grants and private equity investments.
For more information visit http://www.mesabiotech.com.