ISO certification is a Critical Step in Innova Medical Group’s Plans for Expansion into the U.S. in the In Vitro Diagnostics Market
Pasadena, CA, January, 3, 2023 – Innova Medical Group Inc., a global health innovator and a world leader in the development and distribution of rapid diagnostic tests, medical devices and other “Point of Need” self-tests, announced today that its wholly owned subsidiary – MPS – recently received ISO 13485 certification for its Brea, California manufacturing facility. MPS develops and manufactures medical devices to advance healthcare across multiple areas of care including infusion therapy, cell therapy manufacturing, sterile compounding and in-home pharmacy, as well as OEM (Original Equipment Manufacturer) services.
“Earning this certification at our Brea facility is an important progression in our team’s efforts to produce vital in vitro diagnostics (IVD) to detect diseases or other conditions, while also monitoring a person’s overall health to help cure, treat, or prevent diseases,” said Dr. Charles Huang, CEO of Innova Medical Group. “We’re proud of this accomplishment and remain focused on our U.S. expansion and commercialization of our full array of product offerings designed to improve health outcomes for all people with equitable, high-value testing solutions.”
The ISO 13485:2016 certification demonstrates conformity to rigorous international quality standards and the ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO certification provides tangible assurance that a business conforms to the latest quality process standards set by the International Organization for Standardization (ISO), while maintaining consistency and quality across international industries to ensure safety and efficiency in products, services and systems. While ISO sets the standards, certification is granted only after review by an independent certifying body. The ISO certification process is rigorous and comprehensive, and typically takes from six months to one year to complete.
About Innova Medical Group, Inc.
Located in Pasadena, Calif., Innova Medical Group, Inc. is a global leader in the development, manufacture and distribution of rapid tests and diagnostics. Our mission is to transform screening and diagnostics at the point of need to improve health outcomes worldwide and make healthcare affordable, accessible and equitable for all. To learn more, visit www.innovamedgroup.com.
To request an interview or receive further information, please contact Laura Hall at Laura@hallcomms.com.